Identity
- Trade Name
- ENDOCAM FDA UDI
- Generic Name
- Endoscope video camera FDA UDI
- Device Name
- Camera heads EUDAMEDLOGIC 4K CAMERA HEAD C-Mount, 3 chip, 2 programmable camera-head buttons, Sensor size: 1/3" FDA UDI
- Model / Reference
- 10000201142 EUDAMED85525942 EUDAMEDFDA UDI
- Description
- LOGIC 4K CAMERA HEAD C-Mount, 3 chip, 2 programmable camera-head buttons, Sensor size: 1/3" FDA UDI
Identifiers
- Catalog Number
- 85525942 FDA UDI
- Primary DI / UDI-DI
- 04055207063163 EUDAMEDFDA UDI
- Basic UDI-DI
- 405520724072019-0017775NA EUDAMED
- Direct Marketing DI
- 04055207063163 EUDAMED
- 510(k) Number
- K180583 FDA UDI
- FDA Product Code
- FET FDA UDI
- EMDN Code
- Z12020405 SURGICAL CAMERAS EUDAMED
- GMDN Term
- Endoscope video camera FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 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
No
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
Moist Heat or Steam Sterilization FDA UDI
Camera heads by Richard Wolf 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 | 405520724072019-0017775NA | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Richard Wolf GmbH
- EUDAMED SRN
- DE-MF-000007048
Sources (2)
- EUDAMED d0c60c12-7b40-418f-ae6a-0f5a5c28cfc2 61 fields · synced Jun 6, 2026
- FDA UDI 9712f005-76ae-4c5a-b3b1-1b3e9d900805 36 fields · synced May 29, 2026