← Back to catalogue
Sperm DNA Fragmentation Detection Kit (Sperm Chromatin Dispersion Method)
EUDAMEDClass A (EU MDR)
Ref 01902Model 10 Tests/Kit, 20 Tests/Kit
Identity
- Device Name
- Sperm DNA Fragmentation Detection Kit (Sperm Chromatin Dispersion Method) EUDAMED
- Model / Reference
- 10 Tests/Kit, 20 Tests/Kit EUDAMED01902 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974222260631 EUDAMED
- Basic UDI-DI
- 697422226019GX EUDAMED
- Direct Marketing DI
- 06974222260631 EUDAMED
- EMDN Code
- W01030708 STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Greece 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 Dispersion Method) 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 | 697422226019GX | 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 (1)
- EUDAMED a105f6da-9e77-4ee8-bbb6-8af89c834df8 61 fields · synced Jun 17, 2026