Identity
- Trade Name
- VacuumCushion 200x100 FDA UDI
- Generic Name
- Vacuum-mould patient positioning system FDA UDI
- Device Name
- Vacuum Cushion EUDAMEDVacuum Cushion, body support, 200x100cm, 65L FDA UDI
- Model / Reference
- 155510 EUDAMEDVBOS200100 FDA UDI
- Description
- Vacuum Cushion, body support, 200x100cm, 65L FDA UDI
Identifiers
- Catalog Number
- 155510 FDA UDI
- Primary DI / UDI-DI
- 08719425703039 EUDAMEDFDA UDI
- Basic UDI-DI
- 872016816155100JS EUDAMED
- 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
- 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
Yes
FDA UDI
MR Conditional FDA UDI
Category: Vacuum-mould patient positioning system
VacuumCushion 200x100 by Macromedics B.v. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Macromedics B.v.
Sources (2)
- FDA UDI 5001ac0e-1c21-4ea2-8d91-80da6110f312 34 fields · synced Jul 10, 2026
- EUDAMED 58c3c279-40a2-49b3-992f-11dd333d9d16 61 fields · synced Jul 10, 2026