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SureID® PanGlobal Human DNA Identification Kit (Direct)
EUDAMEDClass IVD General (EU MDR)
Ref GA02173
Identity
- Device Name
- SureID® PanGlobal Human DNA Identification Kit (Direct) EUDAMED
- Model / Reference
- GA02173 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937044500880 EUDAMED
- Basic UDI-DI
- B-06937044500880 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
SureID® PanGlobal Human DNA Identification Kit (Direct) by Ningbo HEALTH Gene Technologies Co., LTD. — Class IVD General — IVDD — listed in EUDAMED
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-06937044500880 | 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 d50dc7e9-2c7b-4137-ad76-aca9f61d2b27 61 fields · synced Sep 17, 2026