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Semen Leukocytes Staining Solution (Fluorescent Staining Method)
EUDAMEDClass A (EU MDR)
Ref 04402Model 20 Tests/Kit, 50 Tests/KitRef 04401
Identity
- Device Name
- Semen Leukocytes Staining Solution (Fluorescent Staining Method) EUDAMED
- Model / Reference
- 20 Tests/Kit, 50 Tests/Kit EUDAMED04402 EUDAMED04401 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974222260617 EUDAMED06974222260600 EUDAMED
- Basic UDI-DI
- 697422226044GW EUDAMED
- Direct Marketing DI
- 06974222260617 EUDAMED06974222260600 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
Semen Leukocytes Staining Solution (Fluorescent Staining 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 | 697422226044GW | 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 (2)
- EUDAMED 7fb230ef-16d0-4289-a1ee-1f3528510ed0 61 fields · synced Jul 28, 2026
- EUDAMED 5ded20ae-a0bc-417b-bd42-e98e90decaa0 61 fields · synced May 19, 2026