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Sperm DNA Fragmentation Assay Kit (SCD method)
EUDAMEDClass A (EU MDR)
Ref SDF-110Ref SDF-105
Identity
- Trade Name
- Sperm DNA Fragmentation Assay Kit (SCD method) EUDAMED
- Device Name
- Reproductive Medicine EUDAMED
- Model / Reference
- SDF-110 EUDAMEDSDF-105 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719889117926 EUDAMED04719889117919 EUDAMED
- Basic UDI-DI
- 471988911ReproductiveJ7 EUDAMED
- EMDN Code
- W01030799 HISTOLOGY / CYTOLOGY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy 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 DNA Fragmentation Assay Kit (SCD 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 96e8b109-3942-4524-87b9-60289b1506b5 61 fields · synced Jul 17, 2026
- EUDAMED 5575ae77-8b74-4777-8779-99c03f7bc86a 61 fields · synced May 18, 2026