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BlueBAG BodyFIX 14 Rectangular 750x1025 mm/35 L
EUDAMEDFDA UDIClass I (EU MDR)
Ref P10104-822
Identity
- Trade Name
- BlueBAG BodyFIX 14 Rectangular 750x1025 mm/35 L EUDAMEDBlueBAG BodyFIX 14 Rectangular 750x1025 mm/35 L EUDAMEDBodyFIX FDA UDI
- Generic Name
- Vacuum-mould patient positioning system FDA UDI
- Device Name
- BodyFIX, BlueBAG EUDAMEDBlueBAG™ BodyFIX® 14 Rectangular 750x1025mm/35L vacuum cushions create a comfortable, stable and precise mold of the patient’s position. FDA UDI
- Model / Reference
- P10104-822 EUDAMEDFDA UDI
- Description
- BlueBAG™ BodyFIX® 14 Rectangular 750x1025mm/35L vacuum cushions create a comfortable, stable and precise mold of the patient’s position. FDA UDI
Identifiers
- Catalog Number
- P10104-822 FDA UDI
- Primary DI / UDI-DI
- 04056719000813 EUDAMEDFDA UDI
- Basic UDI-DI
- 04056719BUDI0000000001HU EUDAMED
- Direct Marketing DI
- 04056719000813 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
BlueBAG BodyFIX 14 Rectangular 750x1025 mm/35 L 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 (3)
- EUDAMED dca37d45-e48a-474f-883e-7fa075cfb0a9 61 fields · synced Jun 18, 2026
- FDA UDI ccd17adc-199f-4745-896a-de4149704da5 35 fields · synced May 30, 2026
- EUDAMED 1193fb14-626f-4f2b-9c7c-088e66a8e332 61 fields · synced Jun 18, 2026