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Camera heads for ICG
EUDAMEDFDA UDIClass I (EU MDR)
Ref 85525812Model 10000201488Ref 85525922Model 10000201142
Identity
- Trade Name
- ENDOCAM FDA UDINA FDA UDI
- Generic Name
- Endoscope video camera FDA UDI
- Device Name
- Camera heads for ICG EUDAMEDCamera heads EUDAMEDLOGIC HD CAMERA HEAD CABLE 3M C-Mount, 3 chip, 2 camera-head buttons, Sensor size: 1/3" FDA UDILOGIC HD CAMERA HEAD GREEN For fluorescence imaging with ICG dye, Snap-on locking mechanism, 2 chip, integrated lens f = 24mm, 2 programmable camera-head buttons, Activation/deactivation of near-infrared mode FDA UDI
- Model / Reference
- 10000201488 EUDAMED85525812 EUDAMEDFDA UDI85525922 EUDAMEDFDA UDI10000201142 EUDAMED
- Description
- LOGIC HD CAMERA HEAD CABLE 3M C-Mount, 3 chip, 2 camera-head buttons, Sensor size: 1/3" FDA UDILOGIC HD CAMERA HEAD GREEN For fluorescence imaging with ICG dye, Snap-on locking mechanism, 2 chip, integrated lens f = 24mm, 2 programmable camera-head buttons, Activation/deactivation of near-infrared mode FDA UDI
Identifiers
- Catalog Number
- 85525922 FDA UDI85525812 FDA UDI
- Primary DI / UDI-DI
- 04055207065617 EUDAMEDFDA UDI04055207027387 EUDAMEDFDA UDI
- Basic UDI-DI
- 405520708102019-0028787HZ EUDAMED405520724072019-0017775NA EUDAMED
- Direct Marketing DI
- 04055207065617 EUDAMED04055207027387 EUDAMED
- 510(k) Number
- K212808 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 for ICG 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 | 405520708102019-0028787HZ | 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 (4)
- EUDAMED e22e6a7f-e251-4c49-a1ed-2d60994c525e 61 fields · synced Jul 17, 2026
- FDA UDI b242cc6d-6a9a-4f02-be9b-debe0bf8460b 35 fields · synced May 30, 2026
- FDA UDI e70e167c-a6ac-4000-a37b-72004d4f5774 36 fields · synced May 30, 2026
- EUDAMED 7dbd0837-2690-44f0-9629-4c2af18f1ce7 61 fields · synced Jul 17, 2026