Identity
- Trade Name
- OI-SRG428 Saxena Retinal Grid 428 EUDAMEDSaxena Retinal Grid 428 FDA UDI
- Generic Name
- Ophthalmic diagnostic condensing lens FDA UDI
- Device Name
- Indirect Lenses EUDAMED
- Model / Reference
- 10058 EUDAMEDOI-SRG428 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00630238100588 EUDAMEDFDA UDI
- Basic UDI-DI
- 06302381262739 EUDAMED
- Direct Marketing DI
- 00630238100625 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
High-level Disinfectant FDA UDI
OI-SRG428 Saxena Retinal Grid 428 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 b60ec594-46f5-4694-ad65-1cb85cd0c221 61 fields · synced Jul 9, 2026
- FDA UDI b76e0b96-cd01-4332-92a7-3d7ae86ede32 32 fields · synced May 30, 2026