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OI-28 MaxLight® 28D Binocular Indirect Lens
EUDAMEDFDA UDIClass I (EU MDR)
Ref 658
Identity
- Trade Name
- OI-28 MaxLight® 28D Binocular Indirect Lens EUDAMEDMaxLight® 28D Binocular Indirect Lens FDA UDI
- Generic Name
- Ophthalmic diagnostic condensing lens FDA UDI
- Device Name
- Indirect Lenses EUDAMED
- Model / Reference
- 658 EUDAMEDOI-28 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00630238006583 EUDAMEDFDA UDI
- Basic UDI-DI
- 06302381262739 EUDAMED
- Direct Marketing DI
- 00630238067713 EUDAMED
- FDA Product Code
- HJL FDA UDI
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
- GMDN Term
- Ophthalmic diagnostic condensing lens FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.1380 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
OI-28 MaxLight® 28D Binocular Indirect Lens by Ocular Instruments, Inc. — 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 | 06302381262739 | 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 84ac13f8-04fa-4dec-8b4c-aae6fd6729b4 61 fields · synced Jun 18, 2026
- FDA UDI 5281d491-9d21-402b-a159-368087643401 32 fields · synced May 30, 2026