Identity
- Trade Name
- OPMI LUMERA 300 EUDAMEDFDA UDIOPMI® LUMERA® 300 FDA UDI
- Generic Name
- Ophthalmic surgical microscope FDA UDI
- Device Name
- Surgical Microscope EUDAMEDNo description FDA UDI
- Model / Reference
- OPMI LUMERA 300 EUDAMED6137 EUDAMEDFDA UDI
- Description
- No description FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06977585090013 EUDAMEDFDA UDI06909262061375 FDA UDI
- Basic UDI-DI
- 697758509_001_R7 EUDAMED
- Direct Marketing DI
- 06977585090013 EUDAMED
- FDA Product Code
- FSO FDA UDIHRM FDA UDI
- EMDN Code
- Z12011101 OPERATIVE MICROSCOPES EUDAMED
- GMDN Term
- Ophthalmic surgical microscope FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4700 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
Opmi Lumera 300 by Carl Zeiss Meditec (Suzhou) Co., Ltd. — 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 | 697758509_001_R7 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Carl Zeiss Meditec (Suzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000044920
- Authorised Representative
- Carl Zeiss Meditec AG DE-AR-000007733
Sources (3)
- EUDAMED 785eae30-d072-4dde-a92e-653561411bd8 61 fields · synced Jun 19, 2026
- FDA UDI 9466f68a-7368-402b-85cc-26390b209b3e 33 fields · synced May 30, 2026
- FDA UDI b5ce0121-05e5-4cc6-883a-9eb8adf63e8e 33 fields · synced May 30, 2026