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Auto Kerato-Refractometer Kr-800s
EUDAMEDClass I (EU MDR)
Ref 418489700Model KR-800S
Identity
- Trade Name
- AUTO KERATO-REFRACTOMETER KR-800S EUDAMED
- Device Name
- AUTO KERATO-REFRACTOMETER KR-800S EUDAMEDAUTO KERATO-REFRACTOMETER EUDAMED
- Model / Reference
- KR-800S EUDAMED418489700 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04562123287387 EUDAMED04571130283398 EUDAMED
- Basic UDI-DI
- B-04562123287387 EUDAMED4560126260060U9 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-800s by Topcon Corporation — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04562123287387 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-04562123287387 | 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 b409cff7-86ab-447f-88f1-ef18d73b5279 61 fields · synced Jun 20, 2026
- EUDAMED d6d7ba67-e703-407b-bca4-e7fe32d71f36 61 fields · synced May 17, 2026