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Camera control units
EUDAMEDFDA UDIClass I (EU MDR)
Ref 5522101Model 10000201103
Identity
- Trade Name
- ENDOCAM FDA UDI
- Generic Name
- Endoscopic video image processing unit FDA UDI
- Device Name
- Camera control units EUDAMEDD CAMERA CONTROLLER for connection of sensor endoscopes, Output: 1x HDMI, 1x SDI, Capturing video/images on USB, Resolution: 1920x1080 (HDMI, SDI), 1280x1024 (HDMI), Revolutions: 100-240VAC, 50/60Hz, Dim. (wxhxd) 200x60x220mm FDA UDI
- Model / Reference
- 10000201103 EUDAMED5522101 EUDAMEDFDA UDI
- Description
- D CAMERA CONTROLLER for connection of sensor endoscopes, Output: 1x HDMI, 1x SDI, Capturing video/images on USB, Resolution: 1920x1080 (HDMI, SDI), 1280x1024 (HDMI), Revolutions: 100-240VAC, 50/60Hz, Dim. (wxhxd) 200x60x220mm FDA UDI
Identifiers
- Catalog Number
- 5522101 FDA UDI
- Primary DI / UDI-DI
- 04055207066188 EUDAMEDFDA UDI
- Basic UDI-DI
- 405520724072019-0017684N6 EUDAMED
- Direct Marketing DI
- 04055207066188 EUDAMED
- 510(k) Number
- K211332 FDA UDI
- FDA Product Code
- FET FDA UDI
- EMDN Code
- Z12020406 VIDEO PROCESSORS EUDAMED
- GMDN Term
- Endoscopic video image processing unit 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
Camera control units 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 | 405520724072019-0017684N6 | 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 ce0b884b-a991-492f-9d1f-d7d88d7fe1ce 61 fields · synced Jul 27, 2026
- FDA UDI 3c9654be-9387-4eaa-b7e9-81c98cd6405d 37 fields · synced May 29, 2026