Identity
- Trade Name
- Release Module RM03 EUDAMEDRM03 FDA UDI
- Generic Name
- Ophthalmic examination slit lamp FDA UDI
- Device Name
- Imaging Module EUDAMED
- Model / Reference
- 1023540 EUDAMEDIM 910 FDA UDI
Identifiers
- Catalog Number
- 1023540 FDA UDI
- Primary DI / UDI-DI
- 07640132987676 EUDAMEDFDA UDI
- Basic UDI-DI
- 764013298ImagingMB EUDAMED
- Direct Marketing DI
- 07640132987676 EUDAMED
- FDA Product Code
- PUE FDA UDI
- EMDN Code
- Z12120108 SLIT LAMPS EUDAMED
- GMDN Term
- Ophthalmic examination slit lamp 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
Release Module RM03 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 50667acc-b302-42cf-af97-21cd69de4bb1 61 fields · synced Jun 18, 2026
- FDA UDI ce531589-ce28-47ea-8d87-615d558aa74f 34 fields · synced May 30, 2026