Identity
- Trade Name
- VANTAGE PLUS DIGITAL/ANALOGUE FIXED FOCUS KIT FDA UDI
- Generic Name
- Indirect binocular ophthalmoscope FDA UDI
- Model / Reference
- 1205-P-2035 FDA UDI
Identifiers
- Catalog Number
- 1205-P-2035 FDA UDI
- Primary DI / UDI-DI
- 05055272718806 FDA UDI
- FDA Product Code
- HLJ FDA UDI
- GMDN Term
- Indirect binocular ophthalmoscope 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Indirect binocular ophthalmoscope
Vantage Plus Digital/Analogue Fixed Focus Kit by Keeler Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- HEINE OMEGA®500 — Heine Optotechnik GmbH & Co. KG · 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
- Keeler Limited
Sources (1)
- FDA UDI b03f009b-ab81-4919-b4a0-97ac5ecff7c0 33 fields · synced Jun 1, 2026