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O2M Two Mirror Gonio Diagnostic Lens
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref 5340
Identity
- Trade Name
- O2M Two Mirror Gonio Diagnostic Lens EUDAMED2 Mirror Gonio Diagnostic Lens FDA UDI
- Generic Name
- Gonioscope FDA UDI
- Device Name
- Contact Ophthalmic EUDAMED
- Model / Reference
- 5340 EUDAMEDO2M FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00630238053402 EUDAMEDFDA UDI
- Basic UDI-DI
- 06302381262637 EUDAMED
- Direct Marketing DI
- 00630238053648 EUDAMED
- 510(k) Number
- K895846 FDA UDI
- FDA Product Code
- HKS FDA UDI
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
- GMDN Term
- Gonioscope FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.1660 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
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
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
O2M Two Mirror Gonio Diagnostic 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 | K895846 | 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 ce07e486-b831-4765-ae57-245b3657474c 61 fields · synced Jun 18, 2026
- FDA UDI 0e0bffef-1d9b-486c-a78e-8f13f2bc0c6b 33 fields · synced May 30, 2026
- FDA 510(k) K895846 1 fields · synced May 18, 2026