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REFRACTION SYSTEM Chronos
EUDAMEDFDA UDIClass I (EU MDR)
Ref 1037591-01Model Chronos
Identity
- Trade Name
- REFRACTION SYSTEM Chronos EUDAMEDFDA UDI
- Generic Name
- Automated ophthalmic refractometer FDA UDI
- Device Name
- REFRACTION SYSTEM Chronos EUDAMED
- Model / Reference
- Chronos EUDAMEDFDA UDI1037591-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04571130282520 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04571130282520 EUDAMED
- FDA Product Code
- HKO FDA UDI
- EMDN Code
- Z12120115 OPTOMETERS EUDAMED
- GMDN Term
- Automated ophthalmic refractometer FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.1760 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
REFRACTION SYSTEM Chronos by Topcon Corporation — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04571130282520 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 29661807-f183-4358-9c2e-25ca7d03a943 61 fields · synced Jul 27, 2026
- FDA UDI b4e082f2-96d5-401c-9da1-6749ca61bd29 32 fields · synced May 30, 2026