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Couchtop

EUDAMEDFDA UDI

Class I (EU MDR)

Ref MTM3305Ref MTM3304Ref MTM3303Ref MTIL654015Ref MTIL662502Ref MTIL600712Ref MTIL6521Ref MTIL604915Ref MTIL3020Ref 20VARSUB5Ref MTIL624015Ref MTM6504Ref MTIL3300100Ref MTIL650010Ref MTWBL003Ref MTIL360010Ref MTIL6142Ref MTM3302Ref MTIL6053Ref MTWBL005Ref MTM6502Ref MTIL634215Ref MTIL7110Ref MTIL6150Ref MTIL3310Ref MTIL684115Ref MTIL644115Ref RT-4536KV-100Ref RT-4536-HH01LRef MTIL6054Ref MTIL6668Ref MTIL640040Ref MTM340525Ref MTIL6151Ref MTIL7111Ref PRO360RRef MTIL3151Ref MTIL1006Ref MTIL630112Ref MTIL634315Ref MTIL3705Ref MTIL6664Ref PRO320Ref MTIL6240Ref RT-4900Ref MTIL6024Ref MTIL6673Ref MTM3004Ref MTIL6681Ref MTIL630012Ref MTIL604815Ref MTIL650020Ref MTIL6669Ref MTM3002Ref MTIL6027Ref MTIL6682Ref MTIL3311Ref PRO400Ref MTIL6220Ref MTIL704015Ref MTIL6740Ref MTIL360110Ref MTM6501Ref MTIL6028Ref MTIL6440Ref PRO420Ref MTIL614015Ref MTIL370410Ref MTIL6667Ref MTM6505Ref MTIL6020Ref MTIL634015Ref MTIL6049Ref 20VARSUB10Ref MTIL3950Ref MTIL650011Ref MTM3404Ref MTIL640030Ref MTIL6670Ref MTIL6047Ref MTIL6050Ref MTIL6323Ref MTM6506Ref MTIL6666Ref MTIL602912Ref MTIL6616Ref MTM300210Ref MTIL600612Ref MTIL3352Ref RT-4536-SA01Ref MTIL3652Ref MTIL3019100Ref MTM340410Ref MTIL6679Ref MTIL6661Ref MTIL3020100Ref MTIL604715Ref RT-4536KV-01Ref MTWBL006Ref MTM300404Ref MTIL6684Ref RT-4536-NS65Ref PRO360LRef MTIL3704Ref MTIL6720Ref RT-4536-100Ref MTIL634115Ref MTIL6520Ref MTIL6676Ref MTIL6320Ref MTM340510Ref MTIL6686

by Medtec LLC

Identity

Trade Name
Posifix® Extension FDA UDI
Positioning Cushion FDA UDI
Interface Plate FDA UDI
Docking Station FDA UDI
Universal Couchtop™ FDA UDI
Lok-Bar™ FDA UDI
Reference Device for TrueBeam FDA UDI
Interloc® Lok-Bar™ FDA UDI
Reference Lok-Bar™ FDA UDI
Type-S™ Extension FDA UDI
Universal Couchtop™ MRI Overlay - GE FDA UDI
IPPS™ Overlay FDA UDI
Bridge Adapter FDA UDI
Overlay FDA UDI
Prodigy™ 2 Lok-Bar™ FDA UDI
Coil Support FDA UDI
Posi Indexing Bar FDA UDI
ProForm™ Head and Neck Extension FDA UDI
ProForm™ Pediatric Overlay FDA UDI
Pronumbra FDA UDI
Exact Lok-Bar™ FDA UDI
Universal Couchtop™ MRI Overlay - GE GEM FDA UDI
Rectangular Backrest FDA UDI
Rectangular Extension FDA UDI
Head Coil Support FDA UDI
ThermFix Spacing Tool FDA UDI
Phantom Mount FDA UDI
Body Coil Support FDA UDI
IPPS™ Couchtop FDA UDI
ProForm™ Pediatric Head and Neck Extension FDA UDI
UCT Extra Long Extension FDA UDI
ProForm™ MR Overlay FDA UDI
Mevion Rectangular Backrest FDA UDI
Canon RGSC Adapter Plate FDA UDI
ThermFix Inferior Bar FDA UDI
Toshiba Aquilion Lateral Stabilization Bar FDA UDI
UCT Proton Extension (1349mm) FDA UDI
Interface for Varian FDA UDI
ProForm™ Pediatric MR Overlay FDA UDI
Slide Guide Lok-Bar™ FDA UDI
Patient Handle, Left FDA UDI
UCT XLE Standard Profile FDA UDI
Patient Handle, Right FDA UDI
Patient Hand Grip FDA UDI
Prodigy™ Lok-Bar™ FDA UDI
Body Bridge FDA UDI
Generic Name
Indexed-immobilization patient positioning system FDA UDI
Radiological whole-body positioner FDA UDI
Multi-modality therapeutic radiation phantom, test object FDA UDI
Device Name
Couchtop EUDAMED
For use with Universal Couchtop™ Long Extension FDA UDI
(167.5 x 51 x 5cm) rectangular cushion FDA UDI
For use with Siemens Biograph mCT FDA UDI
For use with Siemens Emotion system FDA UDI
Philips Brilliance CT couchtop with storage rack FDA UDI
Siemens Biograph mCT UCT LE couchtop with Lok-Bar™ FDA UDI
Transverse (50cm) FDA UDI
for use with Prodigy™ 2 Lok-Bar™ FDA UDI
(53cm) FDA UDI
(53cm) Prodigy™*2 FDA UDI
with Prodigy™ 2 Lok-Bar™ eXpress Detachable FDA UDI
Philips Brilliance CT cradle top without extension FDA UDI
For use with Universal Couchtop™ FDA UDI
Couchtop for Mevion with Lok-Bar™ FDA UDI
with Lok-Bar™ for use with Canon Vantage Galan 3T FDA UDI
53cm, non-conductive FDA UDI
GE Hi-Speed CT cradle top without extension FDA UDI
for use with Philips Ingenia MR overlay FDA UDI
For use with MTM3303, MTM3304, MTM3305, MTM3004 FDA UDI
Docking Station, GE FDA UDI
Siemens Vario RT UCT Pedestal with Lok-Bar™ FDA UDI
GE Discovery STCT cradle top without extension FDA UDI
With body coil support, head coil support, and Lok-Bar™ for use with Siemens MR Sola and Vida FDA UDI
ProForm™ XLE (1518mm): For Use with Universal Couchtop™ FDA UDI
Toshiba Aquilion long overlay (231 x 53 x 4.2cm) with Interloc® Lok-Bar™ FDA UDI
For use with Siemens Definition system FDA UDI
For use in Photon and CT FDA UDI
Pronumbra Neck Support, 65mm FDA UDI
Siemens Vario RT CT with Lok-Bar™ , rectangular extension, and storage rack FDA UDI
with Prodigy™ 2 Lok-Bar™ FDA UDI
GE VCT Global 1700 CT cradle top without extension FDA UDI
Siemens Vario 2 UCT Pedestal with Lok-Bar™ FDA UDI
GE VCT Global 2000 CT one piece cradle top FDA UDI
For use with Leo Cancer Care system FDA UDI
couchtop for use with Elekta X-Box base with Lok-Bar™, rectangular extension, and storage rack FDA UDI
For use with Canon Vantage Galan 3T FDA UDI
For use with GE Discovery ST CT FDA UDI
Canon Aquilion CT cradle top Head End Support FDA UDI
For IBA L-Series with Lok-Bar™ FDA UDI
GE Hi-Speed CT one piece cradle top FDA UDI
For use with ThermFix Immobilization System FDA UDI
Pronumbra Helping Hand, Left FDA UDI
with body coil support, head coil support, and Lok-Bar™ for use with Canon Orian FDA UDI
Siemens Definition CT one piece couchtop FDA UDI
For use with Philips Brilliance Universal Couchtop™ FDA UDI
Varian TrueBeam™ Couchtop with Lok-Bar™, rectangular extension and storage rack FDA UDI
Varian Exact™ Couchtop with Lok-Bar™ FDA UDI
Pronumbra Shoulder Adapter FDA UDI
One piece couchtop with Lok-Bar™ FDA UDI
ProForm™ MR Overlay FDA UDI
For use with Mevion S250-FIT Proton Therapy System™ FDA UDI
For use with Siemens Vario RT CT FDA UDI
Canon RGSC Adapter Plate FDA UDI
For use with Type-S™ thermoplastics with Prodigy™ Lok-Bar™ and supports (2) for Siemens MR Aera, Avanto fit, Prisma, Prisma fit, Skyra, Skyra fit, Spectra and Vida FDA UDI
Siemens SOMATOM Emotion overlay with Prodigy™ Lok-Bar™ FDA UDI
Siemens Biograph mCT with Lok-Bar™ , rectangular extension, and storage rack FDA UDI
Canon Aquilion Lateral Stabilization Bar FDA UDI
(223.5 x 51 x 5cm) rectangular cushion FDA UDI
with Prodigy™ 2 Lok-Bar™ Comfort Plus FDA UDI
For use with Elekta X-Box base with Lok-Bar™ FDA UDI
Siemens Vario RT CT one piece couchtop FDA UDI
Pronumbra 130cm kVue FDA UDI
One piece couchtop with Lok-Bar™ for use with Siemens TXT or Proutra™ FDA UDI
For use with Siemens Definition CT FDA UDI
ProForm™ Pediatric MR Overlay FDA UDI
Transverse (48-53cm) FDA UDI
For use with Canon Aquilion CT FDA UDI
53cm FDA UDI
Extension for use with Universal Couchtop™ Long Extension on Varian TrueBeam™ FDA UDI
Toshiba Aquilion CT one piece cradle top FDA UDI
One piece couchtop for use with Elekta X-Box base with Lok-Bar™ FDA UDI
GE Discovery ST overlay with Interloc® Lok-Bar™ FDA UDI
For use with ProForm™ Overlay FDA UDI
Toshiba Aquilion One CT, Canon Cartesion CT one piece cradle top FDA UDI
Toshiba Aquilion short overlay (201 x 53 x 4.2cm) with Interloc® Lok-Bar™ FDA UDI
Extension for use with Universal Couchtop™ Long Extension FDA UDI
Siemens Vario 2 CT one piece couchtop FDA UDI
with Lok-Bar™ and coil supports (2) FDA UDI
Pronumbra 163cm Overlay Package FDA UDI
For use with GE Hi-Speed CT FDA UDI
53cm overlay with Interloc® Lok-Bar™ (2), head extension, coil support, locating blocks (2), and template for use with Philips Ingenia FDA UDI
ProForm™ XSE (935mm): For Use with Universal Couchtop™ FDA UDI
with Lok-Bar™ and rectangular extension FDA UDI
with divergent wires for use with Universal Couchtop™ Long Extension FDA UDI
with body coil support, head coil support, and Lok-Bar™ for use with Canon Vantage Galan 3T FDA UDI
GE VCT Global 2000 CT cradle top without extension FDA UDI
GE Lightspeed VCT and Discovery ST (global base) overlay with Prodigy™ Lok-Bar™ FDA UDI
Transverse (53cm) FDA UDI
Slot clip for use with Siemens MR Aera, Avanto fit, Prisma, Prisma fit, Skyra, Skyra fit, Spectra and Vida FDA UDI
Canon Aquilion CT cradle top without extension FDA UDI
For use with Siemens MR Sola and Vida FDA UDI
Model / Reference
MTM3305 EUDAMEDFDA UDI
MTM3304 EUDAMEDFDA UDI
MTM3303 EUDAMEDFDA UDI
MTIL6666 EUDAMEDFDA UDI
MTIL360110 EUDAMEDFDA UDI
MTIL602912 EUDAMEDFDA UDI
MTIL3020100 EUDAMEDFDA UDI
MTIL6440 EUDAMEDFDA UDI
MTIL604915 EUDAMEDFDA UDI
MTIL3950 EUDAMEDFDA UDI
MTIL6151 EUDAMEDFDA UDI
MTIL3352 EUDAMEDFDA UDI
MTIL6150 EUDAMEDFDA UDI
MTIL6664 EUDAMEDFDA UDI
MTIL644115 EUDAMEDFDA UDI
MTIL6616 EUDAMEDFDA UDI
MTIL704015 EUDAMEDFDA UDI
MTM6506 EUDAMEDFDA UDI
MTIL6053 EUDAMEDFDA UDI
MTIL634015 EUDAMEDFDA UDI
MTM340510 EUDAMEDFDA UDI
MTWBL006 EUDAMEDFDA UDI
MTIL3300100 EUDAMEDFDA UDI
MTIL604715 EUDAMEDFDA UDI
MTIL634115 EUDAMEDFDA UDI
MTM3004 EUDAMEDFDA UDI
MTIL6679 EUDAMEDFDA UDI
MTIL3705 EUDAMEDFDA UDI
MTIL3019100 EUDAMEDFDA UDI
PRO400 EUDAMEDFDA UDI
RT-4536-NS65 EUDAMEDFDA UDI
MTIL6047 EUDAMEDFDA UDI
20VARSUB10 EUDAMEDFDA UDI
MTIL634215 EUDAMEDFDA UDI
MTIL604815 EUDAMEDFDA UDI
MTIL6323 EUDAMEDFDA UDI
MTIL7110 EUDAMEDFDA UDI
MTIL6240 EUDAMEDFDA UDI
MTIL3151 EUDAMEDFDA UDI
MTIL6669 EUDAMEDFDA UDI
MTM6505 EUDAMEDFDA UDI
MTIL630112 EUDAMEDFDA UDI
MTIL650020 EUDAMEDFDA UDI
MTIL684115 EUDAMEDFDA UDI
MTIL6320 EUDAMEDFDA UDI
MTWBL005 EUDAMEDFDA UDI
RT-4536-HH01L EUDAMEDFDA UDI
MTM6502 EUDAMEDFDA UDI
MTIL6024 EUDAMEDFDA UDI
MTIL640040 EUDAMEDFDA UDI
MTIL6054 EUDAMEDFDA UDI
MTIL6142 EUDAMEDFDA UDI
MTM6504 EUDAMEDFDA UDI
MTIL614015 EUDAMEDFDA UDI
RT-4536-SA01 EUDAMEDFDA UDI
MTIL6720 EUDAMEDFDA UDI
MTIL6682 EUDAMEDFDA UDI
MTIL6673 EUDAMEDFDA UDI
MTIL640030 EUDAMEDFDA UDI
PRO320 EUDAMEDFDA UDI
MTIL7111 EUDAMEDFDA UDI
20VARSUB5 EUDAMEDFDA UDI
MTIL600712 EUDAMEDFDA UDI
MTIL370410 EUDAMEDFDA UDI
MTM3002 EUDAMEDFDA UDI
MTIL6050 EUDAMEDFDA UDI
MTIL3020 EUDAMEDFDA UDI
MTWBL003 EUDAMEDFDA UDI
MTIL6049 EUDAMEDFDA UDI
MTIL6686 EUDAMEDFDA UDI
MTIL650011 EUDAMEDFDA UDI
MTIL6684 EUDAMEDFDA UDI
MTIL360010 EUDAMEDFDA UDI
MTIL624015 EUDAMEDFDA UDI
MTIL6667 EUDAMEDFDA UDI
MTIL6027 EUDAMEDFDA UDI
RT-4536KV-01 EUDAMEDFDA UDI
MTIL6020 EUDAMEDFDA UDI
MTIL600612 EUDAMEDFDA UDI
MTM340410 EUDAMEDFDA UDI
PRO420 EUDAMEDFDA UDI
MTIL1006 EUDAMEDFDA UDI
MTIL650010 EUDAMEDFDA UDI
MTM340525 EUDAMEDFDA UDI
MTIL6670 EUDAMEDFDA UDI
MTIL6520 EUDAMEDFDA UDI
MTIL6220 EUDAMEDFDA UDI
MTIL3310 EUDAMEDFDA UDI
PRO360L EUDAMEDFDA UDI
MTIL6521 EUDAMEDFDA UDI
MTIL3704 EUDAMEDFDA UDI
MTIL6676 EUDAMEDFDA UDI
MTIL6028 EUDAMEDFDA UDI
MTM3302 EUDAMEDFDA UDI
PRO360R EUDAMEDFDA UDI
RT-4536-100 EUDAMEDFDA UDI
MTIL630012 EUDAMEDFDA UDI
MTM3404 EUDAMEDFDA UDI
MTIL6681 EUDAMEDFDA UDI
MTIL6740 EUDAMEDFDA UDI
MTIL6661 EUDAMEDFDA UDI
MTM6501 EUDAMEDFDA UDI
MTIL634315 EUDAMEDFDA UDI
MTIL3311 EUDAMEDFDA UDI
MTIL662502 EUDAMEDFDA UDI
MTIL3652 EUDAMEDFDA UDI
MTIL6668 EUDAMEDFDA UDI
MTM300210 EUDAMEDFDA UDI
MTIL654015 EUDAMEDFDA UDI
MTM300404 EUDAMEDFDA UDI
RT-4536KV-100 EUDAMED
RT-4900 EUDAMED
Description
For use with Universal Couchtop™ Long Extension FDA UDI
(167.5 x 51 x 5cm) rectangular cushion FDA UDI
For use with Siemens Biograph mCT FDA UDI
For use with Siemens Emotion system FDA UDI
Philips Brilliance CT couchtop with storage rack FDA UDI
Siemens Biograph mCT UCT LE couchtop with Lok-Bar™ FDA UDI
Transverse (50cm) FDA UDI
for use with Prodigy™ 2 Lok-Bar™ FDA UDI
(53cm) FDA UDI
(53cm) Prodigy™*2 FDA UDI
with Prodigy™ 2 Lok-Bar™ eXpress Detachable FDA UDI
Philips Brilliance CT cradle top without extension FDA UDI
For use with Universal Couchtop™ FDA UDI
Couchtop for Mevion with Lok-Bar™ FDA UDI
with Lok-Bar™ for use with Canon Vantage Galan 3T FDA UDI
53cm, non-conductive FDA UDI
GE Hi-Speed CT cradle top without extension FDA UDI
for use with Philips Ingenia MR overlay FDA UDI
For use with MTM3303, MTM3304, MTM3305, MTM3004 FDA UDI
Docking Station, GE FDA UDI
Siemens Vario RT UCT Pedestal with Lok-Bar™ FDA UDI
GE Discovery STCT cradle top without extension FDA UDI
With body coil support, head coil support, and Lok-Bar™ for use with Siemens MR Sola and Vida FDA UDI
ProForm™ XLE (1518mm): For Use with Universal Couchtop™ FDA UDI
Toshiba Aquilion long overlay (231 x 53 x 4.2cm) with Interloc® Lok-Bar™ FDA UDI
For use with Siemens Definition system FDA UDI
For use in Photon and CT FDA UDI
Pronumbra Neck Support, 65mm FDA UDI
Siemens Vario RT CT with Lok-Bar™ , rectangular extension, and storage rack FDA UDI
with Prodigy™ 2 Lok-Bar™ FDA UDI
GE VCT Global 1700 CT cradle top without extension FDA UDI
Siemens Vario 2 UCT Pedestal with Lok-Bar™ FDA UDI
GE VCT Global 2000 CT one piece cradle top FDA UDI
For use with Leo Cancer Care system FDA UDI
couchtop for use with Elekta X-Box base with Lok-Bar™, rectangular extension, and storage rack FDA UDI
For use with Canon Vantage Galan 3T FDA UDI
For use with GE Discovery ST CT FDA UDI
Canon Aquilion CT cradle top Head End Support FDA UDI
For IBA L-Series with Lok-Bar™ FDA UDI
GE Hi-Speed CT one piece cradle top FDA UDI
For use with ThermFix Immobilization System FDA UDI
Pronumbra Helping Hand, Left FDA UDI
with body coil support, head coil support, and Lok-Bar™ for use with Canon Orian FDA UDI
Siemens Definition CT one piece couchtop FDA UDI
For use with Philips Brilliance Universal Couchtop™ FDA UDI
Varian TrueBeam™ Couchtop with Lok-Bar™, rectangular extension and storage rack FDA UDI
Varian Exact™ Couchtop with Lok-Bar™ FDA UDI
Pronumbra Shoulder Adapter FDA UDI
One piece couchtop with Lok-Bar™ FDA UDI
ProForm™ MR Overlay FDA UDI
For use with Mevion S250-FIT Proton Therapy System™ FDA UDI
For use with Siemens Vario RT CT FDA UDI
Canon RGSC Adapter Plate FDA UDI
For use with Type-S™ thermoplastics with Prodigy™ Lok-Bar™ and supports (2) for Siemens MR Aera, Avanto fit, Prisma, Prisma fit, Skyra, Skyra fit, Spectra and Vida FDA UDI
Siemens SOMATOM Emotion overlay with Prodigy™ Lok-Bar™ FDA UDI
Siemens Biograph mCT with Lok-Bar™ , rectangular extension, and storage rack FDA UDI
Canon Aquilion Lateral Stabilization Bar FDA UDI
(223.5 x 51 x 5cm) rectangular cushion FDA UDI
with Prodigy™ 2 Lok-Bar™ Comfort Plus FDA UDI
For use with Elekta X-Box base with Lok-Bar™ FDA UDI
Siemens Vario RT CT one piece couchtop FDA UDI
Pronumbra 130cm kVue FDA UDI
One piece couchtop with Lok-Bar™ for use with Siemens TXT or Proutra™ FDA UDI
For use with Siemens Definition CT FDA UDI
ProForm™ Pediatric MR Overlay FDA UDI
Transverse (48-53cm) FDA UDI
For use with Canon Aquilion CT FDA UDI
53cm FDA UDI
Extension for use with Universal Couchtop™ Long Extension on Varian TrueBeam™ FDA UDI
Toshiba Aquilion CT one piece cradle top FDA UDI
One piece couchtop for use with Elekta X-Box base with Lok-Bar™ FDA UDI
GE Discovery ST overlay with Interloc® Lok-Bar™ FDA UDI
For use with ProForm™ Overlay FDA UDI
Toshiba Aquilion One CT, Canon Cartesion CT one piece cradle top FDA UDI
Toshiba Aquilion short overlay (201 x 53 x 4.2cm) with Interloc® Lok-Bar™ FDA UDI
Extension for use with Universal Couchtop™ Long Extension FDA UDI
Siemens Vario 2 CT one piece couchtop FDA UDI
with Lok-Bar™ and coil supports (2) FDA UDI
Pronumbra 163cm Overlay Package FDA UDI
For use with GE Hi-Speed CT FDA UDI
53cm overlay with Interloc® Lok-Bar™ (2), head extension, coil support, locating blocks (2), and template for use with Philips Ingenia FDA UDI
ProForm™ XSE (935mm): For Use with Universal Couchtop™ FDA UDI
with Lok-Bar™ and rectangular extension FDA UDI
with divergent wires for use with Universal Couchtop™ Long Extension FDA UDI
with body coil support, head coil support, and Lok-Bar™ for use with Canon Vantage Galan 3T FDA UDI
GE VCT Global 2000 CT cradle top without extension FDA UDI
GE Lightspeed VCT and Discovery ST (global base) overlay with Prodigy™ Lok-Bar™ FDA UDI
Transverse (53cm) FDA UDI
Slot clip for use with Siemens MR Aera, Avanto fit, Prisma, Prisma fit, Skyra, Skyra fit, Spectra and Vida FDA UDI
Canon Aquilion CT cradle top without extension FDA UDI
For use with Siemens MR Sola and Vida FDA UDI

Identifiers

Catalog Number
MTIL6666 FDA UDI
MTIL360110 FDA UDI
MTIL602912 FDA UDI
MTIL3020100 FDA UDI
MTIL6440 FDA UDI
MTIL604915 FDA UDI
MTIL3950 FDA UDI
MTIL6151 FDA UDI
MTIL3352 FDA UDI
MTIL6150 FDA UDI
MTIL6664 FDA UDI
MTM3305 FDA UDI
MTIL644115 FDA UDI
MTIL6616 FDA UDI
MTIL704015 FDA UDI
MTM6506 FDA UDI
MTIL6053 FDA UDI
MTIL634015 FDA UDI
MTM340510 FDA UDI
MTWBL006 FDA UDI
MTIL3300100 FDA UDI
MTIL604715 FDA UDI
MTIL634115 FDA UDI
MTM3004 FDA UDI
MTIL6679 FDA UDI
MTIL3705 FDA UDI
MTIL3019100 FDA UDI
PRO400 FDA UDI
RT-4536-NS65 FDA UDI
MTIL6047 FDA UDI
20VARSUB10 FDA UDI
MTM3303 FDA UDI
MTIL634215 FDA UDI
MTIL604815 FDA UDI
MTIL6323 FDA UDI
MTIL7110 FDA UDI
MTIL6240 FDA UDI
MTIL3151 FDA UDI
MTIL6669 FDA UDI
MTM6505 FDA UDI
MTIL630112 FDA UDI
MTIL650020 FDA UDI
MTIL684115 FDA UDI
MTIL6320 FDA UDI
MTWBL005 FDA UDI
RT-4536-HH01L FDA UDI
MTM6502 FDA UDI
MTIL6024 FDA UDI
MTIL640040 FDA UDI
MTIL6054 FDA UDI
MTIL6142 FDA UDI
MTM6504 FDA UDI
MTIL614015 FDA UDI
RT-4536-SA01 FDA UDI
MTIL6720 FDA UDI
MTIL6682 FDA UDI
MTIL6673 FDA UDI
MTIL640030 FDA UDI
PRO320 FDA UDI
MTIL7111 FDA UDI
20VARSUB5 FDA UDI
MTIL600712 FDA UDI
MTIL370410 FDA UDI
MTM3002 FDA UDI
MTIL6050 FDA UDI
MTIL3020 FDA UDI
MTWBL003 FDA UDI
MTIL6049 FDA UDI
MTIL6686 FDA UDI
MTIL650011 FDA UDI
MTIL6684 FDA UDI
MTIL360010 FDA UDI
MTM3304 FDA UDI
MTIL624015 FDA UDI
MTIL6667 FDA UDI
MTIL6027 FDA UDI
RT-4536KV-01 FDA UDI
MTIL6020 FDA UDI
MTIL600612 FDA UDI
MTM340410 FDA UDI
PRO420 FDA UDI
MTIL1006 FDA UDI
MTIL650010 FDA UDI
MTM340525 FDA UDI
MTIL6670 FDA UDI
MTIL6520 FDA UDI
MTIL6220 FDA UDI
MTIL3310 FDA UDI
PRO360L FDA UDI
MTIL6521 FDA UDI
MTIL3704 FDA UDI
MTIL6676 FDA UDI
MTIL6028 FDA UDI
MTM3302 FDA UDI
PRO360R FDA UDI
RT-4536-100 FDA UDI
MTIL630012 FDA UDI
MTM3404 FDA UDI
MTIL6681 FDA UDI
MTIL6740 FDA UDI
MTIL6661 FDA UDI
MTM6501 FDA UDI
MTIL634315 FDA UDI
MTIL3311 FDA UDI
MTIL662502 FDA UDI
MTIL3652 FDA UDI
MTIL6668 FDA UDI
MTM300210 FDA UDI
MTIL654015 FDA UDI
MTM300404 FDA UDI
Primary DI / UDI-DI
00841439113769 EUDAMEDFDA UDI
00841439113752 EUDAMEDFDA UDI
00841439113776 EUDAMEDFDA UDI
00841439106457 EUDAMEDFDA UDI
00841439104941 EUDAMEDFDA UDI
00841439114292 EUDAMEDFDA UDI
00841439104668 EUDAMEDFDA UDI
00841439106068 EUDAMEDFDA UDI
00841439114308 EUDAMEDFDA UDI
00841439105085 EUDAMEDFDA UDI
00841439110836 EUDAMEDFDA UDI
00841439104842 EUDAMEDFDA UDI
00841439105658 EUDAMEDFDA UDI
00841439110973 EUDAMEDFDA UDI
00841439113905 EUDAMEDFDA UDI
00841439106341 EUDAMEDFDA UDI
00841439113356 EUDAMEDFDA UDI
00841439111796 EUDAMEDFDA UDI
00841439105511 EUDAMEDFDA UDI
00841439105917 EUDAMEDFDA UDI
00841439106808 EUDAMEDFDA UDI
00841439115039 EUDAMEDFDA UDI
00841439104743 EUDAMEDFDA UDI
00841439114544 EUDAMEDFDA UDI
00841439105931 EUDAMEDFDA UDI
00841439113271 EUDAMEDFDA UDI
00841439114193 EUDAMEDFDA UDI
00841439105030 EUDAMEDFDA UDI
00841439104644 EUDAMEDFDA UDI
00841439113943 EUDAMEDFDA UDI
00841439114711 EUDAMEDFDA UDI
00841439113615 EUDAMEDFDA UDI
00841439102190 EUDAMEDFDA UDI
00841439105955 EUDAMEDFDA UDI
00841439114551 EUDAMEDFDA UDI
00841439105894 EUDAMEDFDA UDI
00841439113578 EUDAMEDFDA UDI
00841439105702 EUDAMEDFDA UDI
00841439104705 EUDAMEDFDA UDI
00841439110768 EUDAMEDFDA UDI
00841439111789 EUDAMEDFDA UDI
00841439105795 EUDAMEDFDA UDI
00841439106129 EUDAMEDFDA UDI
00841439112991 EUDAMEDFDA UDI
00841439105863 EUDAMEDFDA UDI
00841439114384 EUDAMEDFDA UDI
00841439114650 EUDAMEDFDA UDI
00841439112694 EUDAMEDFDA UDI
00841439105320 EUDAMEDFDA UDI
00841439113899 EUDAMEDFDA UDI
00841439105528 EUDAMEDFDA UDI
00841439110881 EUDAMEDFDA UDI
00841439111772 EUDAMEDFDA UDI
00841439105627 EUDAMEDFDA UDI
00841439114728 EUDAMEDFDA UDI
00841439106488 EUDAMEDFDA UDI
00841439113936 EUDAMEDFDA UDI
00841439111536 EUDAMEDFDA UDI
00841439106044 EUDAMEDFDA UDI
00841439113158 EUDAMEDFDA UDI
00841439114513 EUDAMEDFDA UDI
00841439102206 EUDAMEDFDA UDI
00841439113646 EUDAMEDFDA UDI
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00841439104927 EUDAMEDFDA UDI
00841439105719 EUDAMEDFDA UDI
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00841439113295 EUDAMEDFDA UDI
00841439115145 EUDAMED
00841439115152 EUDAMED
Basic UDI-DI
8414391OC0007R01B6 EUDAMED
510(k) Number
K180021 FDA UDI
K973842 FDA UDI
K933227 FDA UDI
K080072 FDA UDI
K060737 FDA UDI
FDA Product Code
IXQ FDA UDI
IYE FDA UDI
LNH FDA UDI
EMDN Code
Z12011299 PATIENT POSITIONING INSTRUMENTS – OTHER EUDAMED
Z11039099 VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS – OTHER EUDAMED
Z11019080 VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
GMDN Term
Indexed-immobilization patient positioning system FDA UDI
Radiological whole-body positioner FDA UDI
Multi-modality therapeutic radiation phantom, test object FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
892.1980 FDA UDI
892.5050 FDA UDI
892.1000 FDA UDI
Market of Registration
Netherlands EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDIFDA UDI

Serial Number

Yes

FDA UDIFDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI
MR Conditional FDA UDI

Dimensions & Sizes

Size
Width — 20.1 Inch FDA UDI
Length — 65.9 Inch FDA UDI
Width — 5.7 Inch FDA UDI
Length — 18 Inch FDA UDI
Length — 212 Millimeter FDA UDI
Width — 254 Millimeter FDA UDI
Length — 4.5 Inch FDA UDI
Length — 2011 Millimeter FDA UDI
Width — 609 Millimeter FDA UDI
Width — 17.4 Inch FDA UDI
Length — 25.9 Inch FDA UDI
Width — 12.7 Centimeter FDA UDI
Length — 24.4 Centimeter FDA UDI
Length — 40.8 Centimeter FDA UDI
Width — 8.1 Centimeter FDA UDI
Length — 98.3 Centimeter FDA UDI
Width — 558 Millimeter FDA UDI
Height — 336 Millimeter FDA UDI
Length — 44 Centimeter FDA UDI
Width — 24 Centimeter FDA UDI
Width — 80 Millimeter FDA UDI
Length — 609 Millimeter FDA UDI
Length — 67.06 Inch FDA UDI
Width — 20.87 Inch FDA UDI
Length — 23.94 Inch FDA UDI
Width — 5 Centimeter FDA UDI
Length — 47 Centimeter FDA UDI
Width — 20.08 Inch FDA UDI
Length — 87.99 Inch FDA UDI
Width — 16.9 Inch FDA UDI
Length — 25.5 Inch FDA UDI
Length — 41 Centimeter FDA UDI
Width — 9.6 Inch FDA UDI
Length — 17.4 Inch FDA UDI
Width — 20.9 Inch FDA UDI
Length — 55.3 Inch FDA UDI
Length — 7.91 Inch FDA UDI
Length — 23 Inch FDA UDI

Couchtop by Medtec LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Medtec LLC
EUDAMED SRN
US-MF-000002608
Authorised Representative
CEpartner4U NL-AR-000000111

Sources (222)

  • EUDAMED e21e95eb-be1e-41c0-89dc-26e3be762d81 61 fields · synced Sep 18, 2026
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  • EUDAMED ab2774c5-4744-400a-93df-b90cf684cc08 61 fields · synced May 18, 2026
  • FDA UDI 06f5d605-c131-4082-8fa0-7f2d17330133 36 fields · synced May 22, 2026
  • FDA UDI 30476b35-9426-4603-a474-d9ec9cbfbb7b 37 fields · synced May 25, 2026
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  • FDA UDI 1c3d9ba6-3fdd-4b5a-adc7-c5617ff01ce8 37 fields · synced May 25, 2026
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  • FDA UDI 1d4164e8-2e35-4784-861a-b541cac1685a 36 fields · synced May 29, 2026
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