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Sperm Vitality Assay Kit (Eosin - Nigrosin method)
EUDAMEDClass A (EU MDR)
Ref SVN-020Ref SVN-050
Identity
- Trade Name
- Sperm Vitality Assay Kit (Eosin - Nigrosin method) EUDAMED
- Device Name
- Reproductive Medicine EUDAMED
- Model / Reference
- SVN-020 EUDAMEDSVN-050 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719889118442 EUDAMED04719889118459 EUDAMED
- Basic UDI-DI
- 471988911ReproductiveJ7 EUDAMED
- EMDN Code
- W01030799 HISTOLOGY / CYTOLOGY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class A 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
New Device
No
EUDAMED
Sperm Vitality Assay Kit (Eosin - Nigrosin method) by BaSO Biotech Co., LTD.. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 471988911ReproductiveJ7 | Class A | Active |
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Manufacturer
- Manufacturer
- BaSO Biotech Co., LTD..
- EUDAMED SRN
- TW-MF-000018809
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 8d0a9577-2182-4a32-80c0-afae9ae38b4c 61 fields · synced Aug 4, 2026
- EUDAMED aefaf16b-22a9-40fb-a7ee-c943237c70dc 61 fields · synced May 18, 2026