Identity
- Trade Name
- OSMG Single Mirror Gonio Diagnostic Lens EUDAMED
- Device Name
- Contact Ophthalmic EUDAMED
- Model / Reference
- 819 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00630238008198 EUDAMED
- Basic UDI-DI
- 06302381262637 EUDAMED
- Direct Marketing DI
- 00630238125680 EUDAMED
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
OSMG Single Mirror Gonio Diagnostic Lens by Ocular Instruments, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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 (1)
- EUDAMED a56e9ae9-019c-48c3-bd5b-854e5f5778ab 61 fields · synced Jul 28, 2026