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Gold Ortopedi̇ Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇

by Gold Ortopedi̇ Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ 325 variants

Ref R.70042-13060, E.R.70082-05004, 10922-20018, 70549-04004, E.43062-09305, 40062-90380, 40532-13400, E.44012-09215, 70102-00042, E.40302-11240, 10942-10017, 21052-65050, E.44012-09255, 40652-20018, 40322-12380, 21072-40048, 11172-00005, 40572-00000, 11412-20008, R.70072-10002, 20362-45036, E.43062-10275, R.70063-00004, 47092-00055, E.43002-10405, 12042-20014, 11112-10008, R.70072-10007, 40492-10300, 40342-10220, 40372-00115, E.43002-09405, 20382-65115, 40532-14320, 21292-73060, R.70039-00013, R.70039-00017, 43062-12285, 43062-10295, 21072-40012, 21162-35022, R.70042-11060, 12042-10016, 21052-65060, 40492-08300, 10872-20010, 40552-64095, 40222-00022, R.70039-10017, 21162-35048, 10922-20012

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-8680941561772BL Basic UDI-DI Date23 Apr 2022RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Device Name
REVISION KNEE PROSTHESIS STRAIGHT STEM Ø 13-60 mm (TI)
REVISION KNEE PROSTHESIS TIBIA PLATO HALF WEDGE 5 mm SIZE 4 (TI)
Locking Proximal Lateral Humeral Plate 18 Holes Left (Ti)
TOTAL KNEE PROSTHESES TIBIAL INSERT (C/R) HYPERFLEX 70 / 15 mm (UHMWPE)
INTRAMEDULLARY COMPRESSION NAIL (ICN) TIBIA Ø9X305 mm (TI)
INTRAMEDULLARY FEMORAL NAIL 9 X 380 mm (TI)
GFN MULTI-PURPOSE FEMORAL NAIL Ø 13 X 400 mm LEFT (TI)
INTRAMEDULLARY COMPRESSION NAIL (ICN) HUMERUS Ø9X215mm (TI)
ACETABULAR CUP CEMENTLESS PLASMA / POROUS COATED Ø 42 mm (Ti)
CANNULATED INTRAMEDULLARY RETROGRADE FEMORAL NAIL 11 X 240 mm (TI)
Locking Distal Lateral Fibula Plate 17 Holes Right (Ti)
CANCELLOUS SCREW 32 mm THREADED 6.5 X 50 (TI)
INTRAMEDULLARY COMPRESSION NAIL (ICN) HUMERUS Ø9X255 mm (TI)
INTRAMEDULLARY LOCKING SCREW FOR NAIL Ø 2.0 X 18 mm (TI)
CANNULATED PFN LONG NAIL 12 X 380 mm RIGHT (TI)
CANCELLOUS SCREW 1/3 mm THREADED, 4.0 X 48 mm (TI)
LOCKING LC DCP BROAD PLATE 4.5 mm 5 HOLES (TI)
Femoral Nail Proximal Screw, Locking Screw (Ti)
Locking Distal Posterior Humerus Plate 8 Holes Left (Ti)
REVISION KNEE PROSTHESIS FEMUR POSTERIOR CONDYLE WEDGE 10 mm SIZE 2 (TI)
CORTICAL SCREW 4.5 X 36 mm (TI)
INTRAMEDULLARY COMPRESSION NAIL (ICN) TIBIA Ø10X275 mm (TI)
Revision Knee Prosthesis Tibia Plato Size 4 (B) (Cocr)
LAG COMPRESSION SCREW 55 mm (TI)
INTRAMEDULLARY COMPRESSION NAIL (ICN) FEMUR Ø10X405 mm (TI)
Locking Distal Radius Plate Volar Large 16 Holes Left (Ti)
Locking Proximal Lateral Tibial L Plate 8 Holes Right (Ti)
REVISION KNEE PROSTHESIS FEMUR POSTERIOR CONDYLE WEDGE 10 mm SIZE 7 (TI)
GTN TIBIA NAIL Ø 10 X 300 mm (TI)
PFNA PROXIMAL FEMUR NAIL Ø10X220 mm (TI)
PFNA LAG SCREW 115 mm (TI)
INTRAMEDULLARY COMPRESSION NAIL (ICN) FEMUR Ø9X405 mm (TI)
CANCELLOUS SCREW 16 mm THREADED 6.5 X 115 (TI)
GFN MULTI-PURPOSE FEMORAL NAIL Ø 14 X 320 mm LEFT (TI)
LOCKING CANNULATED SCREW 16 mm THREADED 7.3 X 60 mm (TI)
Revision Knee Prosthesis Tibia Insert Size A-13 (Uhmwpe)
Revision Knee Prosthesis Tibia Insert Size A-17 (Uhmwpe)
INTRAMEDULLARY COMPRESSION NAIL (ICN) TIBIA Ø12X285 mm (TI)
INTRAMEDULLARY COMPRESSION NAIL (ICN) TIBIA Ø10X295 mm (TI)
CANCELLOUS SCREW 1/2 mm THREADED, 4.0 X 12 mm (TI)
LOCKING CANNULATED SCREW 3.5 X 22 mm (TI)
REVISION KNEE PROSTHESIS STRAIGHT STEM Ø 11-60 mm (TI)
Locking Distal Radius Plate Volar Large 16 Holes Right (Ti)
CANCELLOUS SCREW 32 mm THREADED 6.5 X 60 (TI)
GTN TIBIA NAIL Ø 8 X 300 mm (TI)
Locking Olecranon Plate 10 Holes Left (Ti)
FEMORAL NAIL CANNULATED PROXIMAL LOCKING SCREW FOR Ø 6.4 X 95 mm (TI)
LOCKING SCREW FOR NAIL 22 mm (TI)
Revision Knee Prosthesis Tibia Insert Size B-17 (Uhmwpe)
LOCKING CANNULATED SCREW 3.5 X 48 mm (TI)
Locking Proximal Lateral Humeral Plate 12 Holes Left (Ti)
Model / Reference
R.70042-13060, E.R.70082-05004, 10922-20018, 70549-04004, E.43062-09305, 40062-90380, 40532-13400, E.44012-09215, 70102-00042, E.40302-11240, 10942-10017, 21052-65050, E.44012-09255, 40652-20018, 40322-12380, 21072-40048, 11172-00005, 40572-00000, 11412-20008, R.70072-10002, 20362-45036, E.43062-10275, R.70063-00004, 47092-00055, E.43002-10405, 12042-20014, 11112-10008, R.70072-10007, 40492-10300, 40342-10220, 40372-00115, E.43002-09405, 20382-65115, 40532-14320, 21292-73060, R.70039-00013, R.70039-00017, 43062-12285, 43062-10295, 21072-40012, 21162-35022, R.70042-11060, 12042-10016, 21052-65060, 40492-08300, 10872-20010, 40552-64095, 40222-00022, R.70039-10017, 21162-35048, 10922-20012
Primary DI / UDI-DI
D-8680941561772BL, D-8680941566807CH, D-86804198214389U, D-8680941525095AD, D-8680941549398CL, D-8680941542900AN, D-8680419869690DC, D-8680941550097AF, D-8680419867498D4, D-86809415208619Z, D-8680419821698AQ, D-8680419856225BD, D-86809415501349U, D-86809415145019H, D-8680419833585B3, D-8680419856751C7, D-8680419828222AL, D-8680419887762DL, D-8680419835510AJ, D-8680941562922BN, D-868041982400298, D-8680941549473C9, D-8680941560904B6, D-8680941543426AN, D-8680941548766CL, D-8680941569280CJ, D-8680419826990BS, D-8680941563073AZ, D-8680419868259CP, D-8680419833868BJ, D-8680419840460A4, D-8680941548612BQ, D-8680419824767B7, D-8680419887946DY, D-8680419890014AY, D-8680941561147AP, D-8680941561161AH, D-8680941545789CB, D-8680941545574BL, D-8680419856577CF, D-8680419862011A7, D-8680941561710AW, D-8680941569228CG, D-8680419856249BT, D-8680419868075CB, D-86804198206469W, D-8680419870238B2, D-8680419889834E2, D-8680941561239AV, D-8680419862141AM, D-86804198213469N
Basic UDI-DI
B-8680941561772BL, B-8680941566807CH, B-86804198214389U, B-8680941525095AD, B-8680941549398CL, B-8680941542900AN, B-8680419869690DC, B-8680941550097AF, B-8680419867498D4, B-86809415208619Z, B-8680419821698AQ, B-8680419856225BD, B-86809415501349U, B-86809415145019H, B-8680419833585B3, B-8680419856751C7, B-8680419828222AL, B-8680419887762DL, B-8680419835510AJ, B-8680941562922BN, B-868041982400298, B-8680941549473C9, B-8680941560904B6, B-8680941543426AN, B-8680941548766CL, B-8680941569280CJ, B-8680419826990BS, B-8680941563073AZ, B-8680419868259CP, B-8680419833868BJ, B-8680419840460A4, B-8680941548612BQ, B-8680419824767B7, B-8680419887946DY, B-8680419890014AY, B-8680941561147AP, B-8680941561161AH, B-8680941545789CB, B-8680941545574BL, B-8680419856577CF, B-8680419862011A7, B-8680941561710AW, B-8680941569228CG, B-8680419856249BT, B-8680419868075CB, B-86804198206469W, B-8680419870238B2, B-8680419889834E2, B-8680941561239AV, B-8680419862141AM, B-86804198213469N
EMDN Code
P09090501, P09120599, P0909030101, P09120201, P090803010202, P09120699, P09098099, P09120601, P09120603
Device Class
Class III
Class IIb
EU market of registration
Türkiye
Greece

Manufacturer details

EUDAMED SRN
TR-MF-000016470

Other devices from Gold Ortopedi̇ Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇

See all devices from Gold Ortopedi̇ Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ →

Properties

  • Sterile YesEUDAMEDNoEUDAMED
  • Implantable

Other properties (9)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No