Identity
- Trade Name
- Camera Module CM04 70/30 EUDAMEDCM04 FDA UDI
- Generic Name
- Ophthalmic fundus camera FDA UDI
- Device Name
- Imaging Module EUDAMED
- Model / Reference
- 1023138 EUDAMEDIM 910 FDA UDI
Identifiers
- Catalog Number
- 1023138 FDA UDI
- Primary DI / UDI-DI
- 07640132987669 EUDAMEDFDA UDI
- Basic UDI-DI
- 764013298ImagingMB EUDAMED
- Direct Marketing DI
- 07640132987669 EUDAMED
- FDA Product Code
- PUE FDA UDI
- EMDN Code
- Z12120108 SLIT LAMPS EUDAMED
- GMDN Term
- Ophthalmic fundus camera FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 886.1850 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
Camera Module CM04 70/30 by Haag-Streit AG — 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 | 764013298ImagingMB | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Haag-Streit AG
- EUDAMED SRN
- CH-MF-000020981
- Authorised Representative
- Haag-Streit Deutschland GmbH DE-AR-000025462
Sources (2)
- EUDAMED 1129a8ac-861e-4494-8d7b-bb2d5c21cd0f 61 fields · synced Jul 9, 2026
- FDA UDI 9decf7a3-15bc-45cf-aa14-9f87ec217510 34 fields · synced May 30, 2026