← Back to catalogue
2.8v Practitioner Ophth In Case
EUDAMEDClass I (EU MDR)
Ref 1127-P-1005
by Keeler Ltd
Identity
- Trade Name
- 2.8V PRACTITIONER OPHTH IN CASE EUDAMED
- Device Name
- Ophthalmoscope EUDAMED
- Model / Reference
- 1127-P-1005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055272700726 EUDAMED
- Basic UDI-DI
- 50552727OPHTHALMOSCOPES39 EUDAMED
- Direct Marketing DI
- 05055272700726 EUDAMED
- EMDN Code
- Z12120114 OPHTHALMOSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Norway EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
2.8v Practitioner Ophth In Case by Keeler Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 50552727OPHTHALMOSCOPES39 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Keeler Ltd
- EUDAMED SRN
- GB-MF-000009031
- Authorised Representative
- Keeler Europe Distribution, S.L. ES-AR-000001559
Sources (1)
- EUDAMED fe0dd8ca-a5c1-4691-928b-f630931342ce 61 fields · synced Jun 18, 2026