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3.6v Professional Ophth In Carton
EUDAMEDFDA UDIClass I (EU MDR)
Ref 1128-P-1004
by Keeler Ltd
Identity
- Trade Name
- 3.6V PROFESSIONAL OPHTH IN CARTON EUDAMED3.6V PROFESSIONAL OPHTH HEAD ONLY FDA UDI
- Generic Name
- Direct ophthalmoscope FDA UDI
- Device Name
- Ophthalmoscope EUDAMED
- Model / Reference
- 1128-P-1004 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055272700764 EUDAMEDFDA UDI
- Basic UDI-DI
- 50552727OPHTHALMOSCOPES39 EUDAMED
- Direct Marketing DI
- 05055272700764 EUDAMED
- FDA Product Code
- HLI FDA UDI
- EMDN Code
- Z12120114 OPHTHALMOSCOPES EUDAMED
- GMDN Term
- Direct ophthalmoscope FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 886.1570 FDA UDI
- Market of Registration
- Norway 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
3.6v Professional Ophth In Carton 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 | 50552727OPHTHALMOSCOPES39 | 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 d2ca9894-4ba9-446a-a496-82f2860c5a37 61 fields · synced Jul 14, 2026
- FDA UDI 58dbcd3b-031d-4165-b8ec-1679a4da0a60 32 fields · synced May 30, 2026