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Auto Kerato-Refractometer Kr-800
EUDAMEDClass I (EU MDR)
Ref AUTO KERATO-REFRACTOMETER KR-800
Identity
- Trade Name
- AUTO KERATO-REFRACTOMETER KR-800 EUDAMED
- Device Name
- AUTO KERATO-REFRACTOMETER EUDAMED
- Model / Reference
- AUTO KERATO-REFRACTOMETER KR-800 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04560126269140 EUDAMED
- Basic UDI-DI
- 4560126260060U9 EUDAMED
- EMDN Code
- Z12120115 OPTOMETERS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Auto Kerato-Refractometer Kr-800 by Topcon Corporation — 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 | 4560126260060U9 | Class I | Active |
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Manufacturer
- Manufacturer
- Topcon Corporation
- EUDAMED SRN
- JP-MF-000003928
- Authorised Representative
- Topcon Europe Medical BV NL-AR-000000441
Sources (1)
- EUDAMED 34c3fc95-bea0-4619-a129-35861ee7be8b 61 fields · synced Jun 19, 2026