Identity
- Trade Name
- ENDOFIX exo EUDAMEDFDA UDI
- Generic Name
- Surgical camera holder FDA UDI
- Device Name
- ENDOFIX exo EUDAMED
- Model / Reference
- 171943 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260463849431 EUDAMEDFDA UDI
- Basic UDI-DI
- 4260463840028V EUDAMED
- 510(k) Number
- K232405 FDA UDI
- FDA Product Code
- OCV FDA UDI
- EMDN Code
- Z12029099,Z129010 EUDAMED
- GMDN Term
- Surgical camera holder FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- Not 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
ENDOFIX exo by Aktormed GmbH — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K232405 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 4260463840028V | Class I | Active |
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Manufacturer
- Manufacturer
- AKTORmed GmbH
- EUDAMED SRN
- DE-MF-000006136
Sources (3)
- EUDAMED 71e494d8-6f10-445c-90a2-c3993e65c076 61 fields · synced Jul 8, 2026
- FDA UDI f2da40fd-2fef-4cca-bb4d-97c8346f7321 34 fields · synced May 30, 2026
- FDA 510(k) K232405 1 fields · synced May 18, 2026