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Multi-function Auto Eye Testing Instrument
EUDAMEDClass IIa (EU MDR)
Ref TR-8000Ref TR-8200
Identity
- Trade Name
- Multi-function Auto Eye Testing Instrument EUDAMED
- Device Name
- Multi-function Auto Eye Testing Instrument EUDAMED
- Model / Reference
- TR-8000 EUDAMEDTR-8200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971821402202 EUDAMED06971821402219 EUDAMED
- Basic UDI-DI
- 69718214005VE EUDAMED
- Direct Marketing DI
- 06971821402202 EUDAMED06971821402219 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 (2)
- EUDAMED 63adacea-e39a-46ee-acf3-ab738f4f4419 61 fields · synced Jul 29, 2026
- EUDAMED 780b01c2-c629-4b8e-a773-46325254dcbf 61 fields · synced May 19, 2026