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BodyFIX Cover Sheet HIP PLUS 2200x1400 mm (5 PCS)
EUDAMEDFDA UDIClass I (EU MDR)
Ref P10102-301
Identity
- Trade Name
- BodyFIX Cover Sheet HIP PLUS 2200x1400 mm (5 PCS) EUDAMEDBodyFIX FDA UDI
- Generic Name
- Vacuum-mould patient positioning system FDA UDI
- Device Name
- BodyFIX, BlueBAG EUDAMEDBodyFIX® Cover Sheet HIP PLUS 2200x1400mm with sleeve includes five cover sheets. The cover sheets are placed over the patient to generate the vacuum. This set is used for the BodyFIX 14 BlueBAG HIP and Total Body. FDA UDI
- Model / Reference
- P10102-301 EUDAMEDFDA UDI
- Description
- BodyFIX® Cover Sheet HIP PLUS 2200x1400mm with sleeve includes five cover sheets. The cover sheets are placed over the patient to generate the vacuum. This set is used for the BodyFIX 14 BlueBAG HIP and Total Body. FDA UDI
Identifiers
- Catalog Number
- P10102-301 FDA UDI
- Primary DI / UDI-DI
- 04056719000226 EUDAMEDFDA UDI
- Basic UDI-DI
- 04056719BUDI0000000001HU EUDAMED
- Unit of Use DI
- 04056719001872 EUDAMED
- 510(k) Number
- K121530 FDA UDI
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- V0804 PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures) 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
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
BodyFIX Cover Sheet HIP PLUS 2200x1400 mm (5 PCS) by 3C-Medical Intelligence GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 04056719BUDI0000000001HU | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- 3C-Medical Intelligence GmbH
- EUDAMED SRN
- DE-MF-000023763
Sources (2)
- EUDAMED 4fa99018-c457-4755-98a7-493809a98285 61 fields · synced Jun 18, 2026
- FDA UDI f18edb47-83f0-41c4-8bf9-1d6bca8b4e87 35 fields · synced May 29, 2026