← Back to catalogue
Sperm DNA Fragmentation Detection Kit (Sperm Chromatin Structure Assay)
EUDAMEDClass A (EU MDR)
Ref 02403Model 10 Tests/Kit, 20 Tests/Kit, 50 Tests/KitRef 02402
Identity
- Device Name
- Sperm DNA Fragmentation Detection Kit (Sperm Chromatin Structure Assay) EUDAMED
- Model / Reference
- 10 Tests/Kit, 20 Tests/Kit, 50 Tests/Kit EUDAMED02403 EUDAMED02402 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974222260556 EUDAMED06974222260549 EUDAMED
- Basic UDI-DI
- 697422226024GQ EUDAMED
- Direct Marketing DI
- 06974222260556 EUDAMED06974222260549 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zhuhai Cariad Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000033851
- Authorised Representative
- PureCE B.V. NL-AR-000006069
Sources (2)
- EUDAMED e9586790-ceb9-42de-84cf-7bb21c012e6e 61 fields · synced Jul 31, 2026
- EUDAMED 35525245-b8b9-4955-90a4-0fbabd1fb659 61 fields · synced May 19, 2026