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Sperm Nuclear DNA Integrity Kit
EUDAMEDClass IVD General (EU MDR)
Ref 310601HNE,310602HNE
Identity
- Device Name
- Sperm Nuclear DNA Integrity Kit EUDAMED
- Model / Reference
- 310601HNE,310602HNE EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-0186P EUDAMED
- Basic UDI-DI
- B-0186P EUDAMED
- EMDN Code
- W0103080699 REAGENTS FOR FLOW CYTOMETRY - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Sperm Nuclear DNA Integrity Kit by Hunan Wellgrow Biotech Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-0186P | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hunan Wellgrow Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000045201
- Authorised Representative
- JOYSUN GROUP S.L.U ES-AR-000043666
Sources (2)
- EUDAMED 97068002-56f7-438f-a9d2-52940f5f9e84 61 fields · synced Jun 20, 2026
- EUDAMED 97068002-56f7-438f-a9d2-52940f5f9e84-1 61 fields · synced Jun 10, 2026