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Sperm Nuclear Staining Solution (Acridine Orange Method)
EUDAMEDClass A (EU MDR)
Ref 02702Model 10 tests/kit, 20 tests/kit
Identity
- Device Name
- Sperm Nuclear Staining Solution (Acridine Orange Method) EUDAMED
- Model / Reference
- 10 tests/kit, 20 tests/kit EUDAMED02702 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974222260594 EUDAMED
- Basic UDI-DI
- 697422226027GW EUDAMED
- Direct Marketing DI
- 06974222260594 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
Sperm Nuclear Staining Solution (Acridine Orange 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 | 697422226027GW | 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 a03e56f8-98d1-4d06-80ac-74c3261fc7ad 61 fields · synced Jun 18, 2026