Identity
- Trade Name
- BodyFIX Adhesive Tape (Set of 3) EUDAMEDBodyFIX FDA UDI
- Generic Name
- Vacuum-mould patient positioning system FDA UDI
- Device Name
- BodyFIX, BlueBAG EUDAMEDBodyFIX® Adhesive Tape (Set of 3) is a spare tape for fixing the cover sheet against the BodyFIX BlueBAGs. FDA UDI
- Model / Reference
- P10102-307 EUDAMEDFDA UDI
- Description
- BodyFIX® Adhesive Tape (Set of 3) is a spare tape for fixing the cover sheet against the BodyFIX BlueBAGs. FDA UDI
Identifiers
- Catalog Number
- P10102-307 FDA UDI
- Primary DI / UDI-DI
- 04056719000288 EUDAMEDFDA UDI
- Basic UDI-DI
- 04056719BUDI0000000001HU EUDAMED
- Unit of Use DI
- 04056719001919 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
- Italy EUDAMEDGermany 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
BodyFIX Adhesive Tape (Set of 3) 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 (3)
- EUDAMED 4e6d8293-57f4-41b0-8d14-39c0b6d05525 61 fields · synced Jun 20, 2026
- FDA UDI fa5cb8ad-5475-4cf7-b1ab-1df7d128f228 35 fields · synced May 30, 2026
- EUDAMED 05bb83b0-b0a5-49dd-8a20-6ef1367b73b8 61 fields · synced Jun 20, 2026