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O4MAC-LR MaxAC® Four Mirror Gonio Lens w/Large Ring 8.5mm O.D.
EUDAMEDFDA UDIClass I (EU MDR)
Ref 7795
Identity
- Trade Name
- O4MAC-LR MaxAC® Four Mirror Gonio Lens w/Large Ring 8.5mm O.D. EUDAMEDMaxAC® Four Mirror Gonio Lens w/Large Ring 8.5mm O.D. FDA UDI
- Generic Name
- Gonioscope FDA UDI
- Device Name
- Contact Ophthalmic EUDAMED
- Model / Reference
- 7795 EUDAMEDO4MAC-LR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00630238077958 EUDAMEDFDA UDI
- Basic UDI-DI
- 06302381262637 EUDAMED
- Direct Marketing DI
- 00630238077972 EUDAMED
- 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
O4MAC-LR MaxAC® Four Mirror Gonio Lens w/Large Ring 8.5mm O.D. by Ocular Instruments, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 06302381262637 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ocular Instruments Inc.
- EUDAMED SRN
- US-MF-000007216
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 3e64e3f8-46d3-48eb-90cc-1ad00810067c 61 fields · synced Jul 16, 2026
- FDA UDI 1b14ed27-ce22-42c8-89b5-aae32ea10a26 32 fields · synced May 30, 2026