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BodyFIX Indexing Adapter P2 (Set of 3)
EUDAMEDFDA UDIClass I (EU MDR)
Ref P10102-413
Identity
- Trade Name
- BodyFIX Indexing Adapter P2 (Set of 3) EUDAMEDBodyFIX FDA UDI
- Generic Name
- Vacuum-mould patient positioning system FDA UDI
- Device Name
- BodyFIX, BlueBAG EUDAMEDBodyFIX® Indexing Adapter P2 is used for attaching the BodyFIX base plate to indexed tabletops provided by other manufacturers. This is required for using the BodyFIX System on other tabletops. The delivery set of the BodyFIX® Indexing Adapter P2 contains three indexing adapters. FDA UDI
- Model / Reference
- P10102-413 EUDAMEDFDA UDI
- Description
- BodyFIX® Indexing Adapter P2 is used for attaching the BodyFIX base plate to indexed tabletops provided by other manufacturers. This is required for using the BodyFIX System on other tabletops. The delivery set of the BodyFIX® Indexing Adapter P2 contains three indexing adapters. FDA UDI
Identifiers
- Catalog Number
- P10102-413 FDA UDI
- Primary DI / UDI-DI
- 04056719000332 EUDAMEDFDA UDI
- Basic UDI-DI
- 04056719BUDI0000000001HU EUDAMED
- Direct Marketing DI
- 04056719000332 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
BodyFIX Indexing Adapter P2 (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 1fa7c144-61e3-4586-ae32-b70b8d4eeb63 61 fields · synced Jul 9, 2026
- FDA UDI fb19879a-eaec-424f-8b1d-9d18b225cddd 35 fields · synced May 30, 2026
- EUDAMED 862edfb1-65ee-4c8d-b910-d1ee5829cbda 61 fields · synced Jul 9, 2026