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Vacuum Lock Cushion
EUDAMEDFDA UDIClass I (EU MDR)
Ref Various catalogue numbersModel Vacuum Lock Cushion Series
Identity
- Trade Name
- Vacuum Lock Cushion EUDAMEDVacuum Lock FDA UDI
- Generic Name
- Vacuum-mould patient positioning system FDA UDI
- Device Name
- Vacuum Lock Cushion EUDAMEDFDA UDI
- Model / Reference
- Vacuum Lock Cushion Series EUDAMEDVarious catalogue numbers EUDAMED1 FDA UDI
- Description
- Vacuum Lock Cushion FDA UDI
Identifiers
- Catalog Number
- VB FDA UDI
- Primary DI / UDI-DI
- 00628341930161 EUDAMEDFDA UDI
- Basic UDI-DI
- 62834193108C EUDAMED
- 510(k) Number
- K122888 FDA UDI
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z12011280 PATIENT POSITIONING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Vacuum-mould patient positioning system 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
Vacuum Lock Cushion 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 | 62834193108C | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- CDR Systems Inc.
- EUDAMED SRN
- CA-MF-000051790
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 99cf5475-2970-40b5-915a-f206ec51bfaa 61 fields · synced Jun 19, 2026
- FDA UDI 9b29c493-e7b0-4b4c-8800-1a4d5fc9d4f5 36 fields · synced May 30, 2026