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Multi-function Auto Eye Testing Instrument
EUDAMEDClass IIa (EU MDR)
Ref VX105Model TR-8000
Identity
- Device Name
- Multi-function Auto Eye Testing Instrument EUDAMED
- Model / Reference
- TR-8000 EUDAMEDVX105 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971821402226 EUDAMED
- Basic UDI-DI
- 69718214005VE EUDAMED
- Direct Marketing DI
- 06971821402226 EUDAMED
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
Multi-function Auto Eye Testing Instrument by Ningbo Ming Sing Optical R&D Co., Ltd. — Class IIa — 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 | 69718214005VE | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ningbo Ming Sing Optical R&D Co., Ltd.
- EUDAMED SRN
- CN-MF-000012092
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 61b6b39b-44e4-4cfc-be67-4c64bb4783a7 61 fields · synced Jun 18, 2026