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Auto Refractometer Rm-800
EUDAMEDFDA UDIClass I (EU MDR)
Ref 418469950Model RM-800
Identity
- Trade Name
- AUTO REFRACTOMETER RM-800 EUDAMEDFDA UDI
- Generic Name
- Automated ophthalmic refractometer FDA UDI
- Device Name
- AUTO REFRACTOMETER RM-800 EUDAMEDAUTO REFRACTOMETER EUDAMED
- Model / Reference
- RM-800 EUDAMEDFDA UDI418469950 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04571130282360 EUDAMEDFDA UDI04560126269164 EUDAMED
- Basic UDI-DI
- B-04571130282360 EUDAMED4560126260050U6 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
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
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
Auto Refractometer Rm-800 by Topcon Corporation — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04571130282360 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-04571130282360 | 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 (3)
- EUDAMED bb272a5d-99fd-4ff2-a308-a6daa3a9095b 61 fields · synced Jul 21, 2026
- EUDAMED 5c85c8c4-5f07-4d34-abd4-6ad4467d8afc 61 fields · synced May 17, 2026
- FDA UDI 2ab7d7a6-2449-419b-b39d-9fc621befc66 32 fields · synced May 30, 2026