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Auto Refracto-Keratometers
EUDAMEDClass I (EU MDR)
Ref 06976684150017Model RM/RK-600, RM/RK-800, ARK-1, ARK7800L, AR/ARK7610, AR/ARK7680, FA-6100/FA-6100K, FKR-710, RM/RMK-960, RM/RMK-980, RM/RMK-990, SW-800, TPV-A easy ref
Identity
- Device Name
- AUTO REFRACTO-KERATOMETERS EUDAMED
- Model / Reference
- RM/RK-600, RM/RK-800, ARK-1, ARK7800L, AR/ARK7610, AR/ARK7680, FA-6100/FA-6100K, FKR-710, RM/RMK-960, RM/RMK-980, RM/RMK-990, SW-800, TPV-A easy ref EUDAMED06976684150017 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976684150017 EUDAMED
- Basic UDI-DI
- 6976684150017F9 EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Auto Refracto-Keratometers by Shanghai Top View Industrial Co Ltd — 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 | 6976684150017F9 | Class I | Active |
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Manufacturer
- Manufacturer
- Shanghai Top View Industrial Co Ltd
- EUDAMED SRN
- CN-MF-000037515
- Authorised Representative
- Everbiz GmbH DE-AR-000008964
Sources (1)
- EUDAMED e4bfdeee-64fd-4253-a0e8-f1fd095eec10 61 fields · synced Jul 14, 2026