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3.6v Professional Ophth In Case
EUDAMEDFDA UDIClass I (EU MDR)
Ref 1128-P-1014
by Keeler Ltd
Identity
- Trade Name
- 3.6V PROFESSIONAL OPHTH IN CASE EUDAMEDFDA UDI
- Generic Name
- Direct ophthalmoscope FDA UDI
- Device Name
- Ophthalmoscope EUDAMED
- Model / Reference
- 1128-P-1014 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055272700788 EUDAMEDFDA UDI
- Basic UDI-DI
- 50552727OPHTHALMOSCOPES39 EUDAMED
- Direct Marketing DI
- 05055272700788 EUDAMED
- FDA Product Code
- HKL FDA UDI
- EMDN Code
- Z12120114 OPHTHALMOSCOPES EUDAMED
- GMDN Term
- Direct ophthalmoscope FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 886.1780 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
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 Case 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 0c6920a6-9284-4370-9a35-5c1e7b666408 61 fields · synced Jul 31, 2026
- FDA UDI 685ff4c2-905e-49a3-91a0-5b2f12231c4b 32 fields · synced May 30, 2026