Identity
- Trade Name
- ImageCam 3 EUDAMEDImageCam 3 (Adapt.: Zeiss, Takagi) FDA UDI
- Generic Name
- Ophthalmic examination slit lamp FDA UDI
- Device Name
- ImageCam EUDAMEDImageCam 3 (Adapt.: Zeiss, Takagi) FDA UDI
- Model / Reference
- 69210 EUDAMEDFDA UDI
- Description
- ImageCam 3 (Adapt.: Zeiss, Takagi) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049584026675 EUDAMEDFDA UDI
- Basic UDI-DI
- 404958415PW EUDAMED
- FDA Product Code
- KQM FDA UDI
- EMDN Code
- Z12129099 VARIOUS OPHTALMOLOGY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Ophthalmic examination slit lamp FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4160 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
ImageCam 3 by OCULUS Optikgeräte 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 | 404958415PW | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- OCULUS Optikgeräte GmbH
- EUDAMED SRN
- DE-MF-000012227
Sources (2)
- EUDAMED 160d33af-7860-4740-a071-ca8683efca71 61 fields · synced Jul 30, 2026
- FDA UDI afbdfa00-6d71-4748-af2a-c4e43c3519fd 34 fields · synced May 22, 2026