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SureID®27Y Human STR Identification Kit(Direct)
EUDAMEDClass IVD General (EU MDR)
Ref 1040015Ref GY01193
Identity
- Device Name
- SureID®27Y Human STR Identification Kit(Direct) EUDAMEDSureID®27Y Human STR Identification Kit EUDAMED
- Model / Reference
- 1040015 EUDAMEDGY01193 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937044500941 EUDAMED06937044500934 EUDAMED
- Basic UDI-DI
- B-06937044500941 EUDAMEDB-06937044500934 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®27Y Human STR 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-06937044500941 | 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 (2)
- EUDAMED a0b9e6da-6500-4def-903e-1546804e2ce1 61 fields · synced Sep 17, 2026
- EUDAMED e5722800-6c60-484d-9f88-5bf0ff1d9c7e 61 fields · synced May 18, 2026