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Vantage Plus Led/Slimline Kit A
EUDAMEDFDA UDIClass I (EU MDR)
Ref 1205-P-1016
by Keeler Ltd
Identity
- Trade Name
- VANTAGE PLUS LED/SLIMLINE KIT A EUDAMEDVANTAGE+ LED SLIMLINE KIT A FDA UDI
- Generic Name
- Indirect binocular ophthalmoscope FDA UDI
- Device Name
- Indirect Ophthalmoscope EUDAMED
- Model / Reference
- 1205-P-1016 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055272711272 EUDAMEDFDA UDI
- Basic UDI-DI
- 50552727INDOSCOPES5Q EUDAMED
- Direct Marketing DI
- 05055272711272 EUDAMED
- FDA Product Code
- HLI FDA UDI
- EMDN Code
- Z12120114 OPHTHALMOSCOPES EUDAMED
- GMDN Term
- Indirect binocular ophthalmoscope FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 886.1570 FDA UDI
- Market of Registration
- Ireland 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Vantage Plus Led/Slimline Kit A by Keeler Ltd — 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 | 50552727INDOSCOPES5Q | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Keeler Ltd
- EUDAMED SRN
- GB-MF-000009031
- Authorised Representative
- Keeler Europe Distribution, S.L. ES-AR-000001559
Sources (2)
- EUDAMED fcd51534-32df-4a87-a1dd-4b59d5778030 61 fields · synced Jun 17, 2026
- FDA UDI dd07eb91-3a05-45c6-8ee9-67b4cc38b71a 32 fields · synced May 30, 2026