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BlueBAG Rectangular 1000x2300 mm/80 L
EUDAMEDFDA UDIClass I (EU MDR)
Ref P10104-159Ref P10104-143
Identity
- Trade Name
- BlueBAG Rectangular 1000x2300 mm/80 L EUDAMEDBlueBAG Rectangular 1000x1500 mm/80 L EUDAMEDBodyFIX FDA UDI
- Generic Name
- Vacuum-mould patient positioning system FDA UDI
- Device Name
- BodyFIX, BlueBAG EUDAMEDBlueBAG™ Rectangular 1000x1500mm/80L vacuum cushions create a comfortable, stable and precise mold of the patient’s position. FDA UDIBlueBAG™ Rectangular 1000x2300mm/80L vacuum cushions create a comfortable, stable and precise mold of the patient’s position. FDA UDI
- Model / Reference
- P10104-159 EUDAMEDFDA UDIP10104-143 EUDAMEDFDA UDI
- Description
- BlueBAG™ Rectangular 1000x1500mm/80L vacuum cushions create a comfortable, stable and precise mold of the patient’s position. FDA UDIBlueBAG™ Rectangular 1000x2300mm/80L vacuum cushions create a comfortable, stable and precise mold of the patient’s position. FDA UDI
Identifiers
- Catalog Number
- P10104-143 FDA UDIP10104-159 FDA UDI
- Primary DI / UDI-DI
- 04056719000615 EUDAMEDFDA UDI04056719000585 EUDAMEDFDA UDI
- Basic UDI-DI
- 04056719BUDI0000000001HU EUDAMED
- Direct Marketing DI
- 04056719000615 EUDAMED04056719000585 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 Rectangular 1000x2300 mm/80 L by 3C-Medical Intelligence GmbH — 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 | 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 (6)
- EUDAMED fb3b8208-6aa2-4adf-86ed-114a2e8b9fab 61 fields · synced Jul 30, 2026
- EUDAMED f6b76f15-a166-497a-91ab-f95e09b2f1d2 61 fields · synced May 18, 2026
- FDA UDI 2c2930cc-20ff-447e-a589-8d9af02e81e8 35 fields · synced May 29, 2026
- FDA UDI a391fa46-718d-4d75-b845-5f6d36727a39 35 fields · synced May 30, 2026
- EUDAMED c6fb76bd-1a47-4861-bc9d-c66d41f38dab 61 fields · synced Jul 14, 2026
- EUDAMED 400d09cf-b4a2-4001-9c7f-1b3d1ae94456 61 fields · synced Jul 30, 2026