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ALDH2 Genotyping Kit (PCR Capillary Electrophoresis Fragment Analysis）
EUDAMEDClass IVD General (EU MDR)
Ref 1060052
Identity
- Device Name
- ALDH2 Genotyping Kit (PCR Capillary Electrophoresis Fragment Analysis） EUDAMED
- Model / Reference
- 1060052 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937044500828 EUDAMED
- Basic UDI-DI
- B-06937044500828 EUDAMED
- EMDN Code
- W010699 GENETIC TESTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
ALDH2 Genotyping Kit (PCR Capillary Electrophoresis Fragment Analysis） by Ningbo HEALTH Gene Technologies Co., LTD. — Class IVD General — IVDD — listed in…
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06937044500828 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Ningbo HEALTH Gene Technologies Co., LTD.
- EUDAMED SRN
- CN-MF-000002278
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED fd71b4db-8ea6-4d7d-a0b7-5d8b23c45142 61 fields · synced Jul 28, 2026