Identity
- Trade Name
- HEINE OMEGA®500 FDA UDI
- Generic Name
- Indirect binocular ophthalmoscope, line-powered FDA UDI
- Model / Reference
- L FDA UDI
Identifiers
- Catalog Number
- C-004.33.530 FDA UDI
- Primary DI / UDI-DI
- 04053755188406 FDA UDI
- FDA Product Code
- HLI FDA UDI
- GMDN Term
- Indirect binocular ophthalmoscope, line-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.1570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Indirect binocular ophthalmoscope, line-powered
Heine Omega®500 by Heine Optotechnik GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Indirect binocular ophthalmoscope, line-powered.
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- Eli Ezer — U.S. OPHTHALMIC, L.L.C. · Class II
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- SLIMLINE BATTERY CHARGER & CARTON — KEELER LIMITED · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Heine Optotechnik GmbH & Co. KG
Sources (1)
- FDA UDI c7bdead0-8395-4fba-8d4a-6e1a9465664e 34 fields · synced May 30, 2026