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Sperm DNA Fragmentation Detection Kit (Sperm Chromatin Structure Assay)
EUDAMEDClass A (EU MDR)
Ref 02401Model 10 Tests/Kit, 20 Tests/Kit, 50 Tests/Kit
Identity
- Device Name
- Sperm DNA Fragmentation Detection Kit (Sperm Chromatin Structure Assay) EUDAMED
- Model / Reference
- 10 Tests/Kit, 20 Tests/Kit, 50 Tests/Kit EUDAMED02401 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974222260532 EUDAMED
- Basic UDI-DI
- 697422226024GQ EUDAMED
- Direct Marketing DI
- 06974222260532 EUDAMED
- EMDN Code
- W01030708 STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Czechia 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 Detection Kit (Sperm Chromatin Structure Assay) by Zhuhai Cariad Medical Technology Co., Ltd. — Class A — IVDR — listed in EUDAMED
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 | 697422226024GQ | Class A | Active |
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Manufacturer
- Manufacturer
- Zhuhai Cariad Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000033851
- Authorised Representative
- PureCE B.V. NL-AR-000006069
Sources (1)
- EUDAMED 0607d8b3-a6ab-471c-a209-7401600681db 61 fields · synced Jun 18, 2026