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OMRA-HM Mainster High Magnification Laser Lens
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref 699
Identity
- Trade Name
- OMRA-HM Mainster High Magnification Laser Lens EUDAMEDMainster High Magnification Laser Lens FDA UDI
- Generic Name
- Laser lens, ophthalmic, surgical FDA UDI
- Device Name
- Contact Ophthalmic EUDAMED
- Model / Reference
- 699 EUDAMEDOMRA-HM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00630238006996 EUDAMEDFDA UDI
- Basic UDI-DI
- 06302381262637 EUDAMED
- Direct Marketing DI
- 00630238020541 EUDAMED
- 510(k) Number
- K912366 FDA UDI
- FDA Product Code
- HJK FDA UDI
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
- GMDN Term
- Laser lens, ophthalmic, surgical FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 886.1385 FDA UDI
- Market of Registration
- Austria 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
High-level Disinfectant FDA UDI
OMRA-HM Mainster High Magnification Laser Lens by Ocular Instruments, Inc. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K912366 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 06302381262637 | Class I | Active |
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Manufacturer
- Manufacturer
- Ocular Instruments Inc.
- EUDAMED SRN
- US-MF-000007216
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED d4b57d0d-e78f-456f-b3e2-247a57ada906 61 fields · synced Jun 19, 2026
- FDA UDI 5e642473-1ef6-45fa-a1e0-33f331c7d823 33 fields · synced May 30, 2026
- FDA 510(k) K912366 1 fields · synced May 18, 2026