← Back to catalogue
Wedges, Supports & Positioning Aids
EUDAMEDFDA UDIClass I (EU MDR)
Ref Multiple catalogue numbersModel Positioning Aid Series
Identity
- Trade Name
- Wedges, Supports & Positioning Aids EUDAMEDPositioning Aids FDA UDI
- Generic Name
- Freestanding patient positioner, reusable FDA UDI
- Device Name
- Wedges, Supports & Positioning Aids EUDAMEDWedges, supports and positioning aids FDA UDI
- Model / Reference
- Positioning Aid Series EUDAMEDMultiple catalogue numbers EUDAMED1 FDA UDI
- Description
- Wedges, supports and positioning aids FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00628341930130 EUDAMEDFDA UDI
- Basic UDI-DI
- 62834193088R EUDAMED
- 510(k) Number
- K122888 FDA UDI
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z12011280 PATIENT POSITIONING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Freestanding patient positioner, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Market of Registration
- France 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
Wedges, Supports & Positioning Aids by CDR Systems Inc — 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 62834193088R | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- CDR Systems Inc.
- EUDAMED SRN
- CA-MF-000051790
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED a7dbae57-5b96-493b-9731-e74e53b0594b 61 fields · synced Jun 18, 2026
- FDA UDI 31eaf150-14b3-48e8-ab96-62b9244a0f38 35 fields · synced May 30, 2026