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Staining Solution for the Maturity of Spermatozoan Nucleoprotein (Aniline Blue-…
EUDAMEDClass A (EU MDR)
Ref 00501Model 20 tests/kit
Identity
- Device Name
- Staining Solution for the Maturity of Spermatozoan Nucleoprotein (Aniline Blue-Eosin Staining) EUDAMED
- Model / Reference
- 20 tests/kit EUDAMED00501 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974222260464 EUDAMED
- Basic UDI-DI
- 697422226005GL EUDAMED
- Direct Marketing DI
- 06974222260464 EUDAMED
- EMDN Code
- W01030708 STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY) 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
Staining Solution for the Maturity of Spermatozoan Nucleoprotein (Aniline Blue-… by Zhuhai Cariad Medical Technology Co., Ltd. — Class A — IVDR — listed in…
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 | 697422226005GL | 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 99a57dc3-44a1-4474-84b6-7c693876d8d6 61 fields · synced Jul 10, 2026