Identity
- Trade Name
- ARC 532nm EUDAMED
- Device Name
- Laser Indirect Ophthalmoscope EUDAMED
- Model / Reference
- 1205-P-2090 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055272718813 EUDAMED
- Basic UDI-DI
- B-05055272718813 EUDAMED
- EMDN Code
- Z12120199 OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
ARC 532nm by Keeler Ltd — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05055272718813 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Keeler Ltd
- EUDAMED SRN
- GB-MF-000009031
- Authorised Representative
- Keeler Europe Distribution, S.L. ES-AR-000001559
Sources (1)
- EUDAMED d05643f6-6e44-4db4-b314-4680d9d4e5ef 61 fields · synced Jul 20, 2026