← Back to catalogue
Respiratory Suppr. Plate, S
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 123400Ref 123530Ref 123700Ref 123660
Identity
- Trade Name
- Respiratory Suppr. Plate, S FDA UDISBRT Secure Arch, size L FDA UDISBRT Secure Arch, size XS FDA UDI
- Generic Name
- Indexed-immobilization patient positioning system FDA UDI
- Device Name
- Secure Arch EUDAMEDRespiratory Suppression Plate for SBRT Secure Arches, size S FDA UDISBRT Secure Arch, size L FDA UDISBRT Secure Arch, size XS FDA UDI
- Model / Reference
- 123400 EUDAMED123530 EUDAMED123700 EUDAMED123660 EUDAMEDEA-BPPS FDA UDISSA-L FDA UDISSA-XS FDA UDI
- Description
- Respiratory Suppression Plate for SBRT Secure Arches, size S FDA UDISBRT Secure Arch, size L FDA UDISBRT Secure Arch, size XS FDA UDI
Identifiers
- Catalog Number
- 123530 FDA UDI123400 FDA UDI123700 FDA UDI
- Primary DI / UDI-DI
- 08719425702629 EUDAMEDFDA UDI08719425702612 EUDAMEDFDA UDI08719425702582 EUDAMEDFDA UDI08720168160096 EUDAMED
- Basic UDI-DI
- 872016816123600J4 EUDAMED
- 510(k) Number
- K142420 FDA UDI
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z12011280 PATIENT POSITIONING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Indexed-immobilization patient positioning system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Market of Registration
- Northern Ireland 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 UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Indexed-immobilization patient positioning system
Respiratory Suppr. Plate, S by Macromedics B.v. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Indexed-immobilization patient positioning system.
- QUANTUM™ CT Overlay — Qfix · Class II
- KLARITY MEDICAL — Klarity Medical Products, LLC · Class II
- KLARITY MEDICAL — Klarity Medical Products, LLC · Class II
- KLARITY MEDICAL — Klarity Medical Products, LLC · Class II
- IPPS™ Overlay — Medtec LLC · Class II
- KLARITY MEDICAL — Klarity Medical Products, LLC · Class II
- KLARITY MEDICAL — Klarity Medical Products, LLC · Class II
- Arm Support, Single Adjust, Elekta Compatible — Aktina Corp. · Class II
Cleared under the same submission
K142420 also covers:
- Adaptor MaxSupport™ TO — MACROMEDICS B.V.
- Adaptor MaxSupport™ TS — MACROMEDICS B.V.
- Block high CF ExaFix™ — MACROMEDICS B.V.
- Block low CF ExaFix™ — MACROMEDICS B.V.
- BreastBoardLX™ — MACROMEDICS B.V.
- CouchStrip CSMF — MACROMEDICS B.V.
- CouchStrip CSMFGF — MACROMEDICS B.V.
- CouchStrip CSNF — MACROMEDICS B.V.
- CouchStrip CSNFCF — MACROMEDICS B.V.
- CouchStrip CSWF — MACROMEDICS B.V.
- DSCP™ KS indexstrip — MACROMEDICS B.V.
- DSPS® Cradle-MEXF H MR — MACROMEDICS B.V.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Macromedics B.v.
Sources (7)
- FDA UDI 61856136-fd43-4c1e-99f6-7465609ccc0f 35 fields · synced Aug 1, 2026
- FDA UDI 4c58e5fe-3ab6-459b-9664-0723a0835768 35 fields · synced May 30, 2026
- FDA UDI ec201421-24fa-46f2-98af-095fb1dc9b08 35 fields · synced May 30, 2026
- EUDAMED 51d3458c-f4f5-4fbf-a5fc-9d507568c976 61 fields · synced Jun 20, 2026
- EUDAMED 79dab087-2323-42f1-9544-80da8d75672d 61 fields · synced Jul 12, 2026
- EUDAMED f2d6c71f-3746-44be-bda9-25f29f83e50d 61 fields · synced Jul 14, 2026
- EUDAMED a5e5306d-6b4a-4a32-88df-edad1f37fff2 61 fields · synced Aug 1, 2026