Identity
- Trade Name
- ARKM-150 EUDAMED
- Device Name
- Auto RefKerato EUDAMED
- Model / Reference
- ARKM-150 EUDAMEDB16003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04560323644696 EUDAMED
- Basic UDI-DI
- B-04560323644696 EUDAMED
- EMDN Code
- Z12120199 OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Arkm-150 by Takagi seiko — Class IIa — 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-04560323644696 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Takagi seiko
- EUDAMED SRN
- JP-MF-000008791
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 8f6ed803-2a81-46f9-8cdb-514f092e39a2 61 fields · synced Jun 19, 2026
- EUDAMED 43acd973-52cc-4f63-ad05-957eabfee6d9 61 fields · synced Jun 14, 2026