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Wave-Front Analyzer Kr-1w
EUDAMEDClass I (EU MDR)
Ref 418359330Model KR-1WRef 418359331
Identity
- Trade Name
- WAVE-FRONT ANALYZER KR-1W EUDAMED
- Device Name
- WAVE-FRONT ANALYZER KR-1W EUDAMED
- Model / Reference
- KR-1W EUDAMED418359330 EUDAMED418359331 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04562123285345 EUDAMED04562123289640 EUDAMED
- Basic UDI-DI
- B-04562123285345 EUDAMEDB-04562123289640 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
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
Wave-Front Analyzer Kr-1w by Topcon Corporation — Class I — 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-04562123285345 | 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 (2)
- EUDAMED 3e549da0-6b46-4a25-a122-e2a8ce3e2dfb 61 fields · synced Aug 5, 2026
- EUDAMED e5c3c8f6-8b03-4705-a04b-b32f6a208971 61 fields · synced May 19, 2026