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Sperm Vitality Staining Solution (Eosin-Nigrosin Staining)
EUDAMEDClass A (EU MDR)
Ref 00701Model 20 tests/kit, 40 tests/kitRef 00702
Identity
- Device Name
- Sperm Vitality Staining Solution (Eosin-Nigrosin Staining) EUDAMED
- Model / Reference
- 20 tests/kit, 40 tests/kit EUDAMED00701 EUDAMED00702 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974222260471 EUDAMED06974222260488 EUDAMED
- Basic UDI-DI
- 697422226007GQ EUDAMED
- Direct Marketing DI
- 06974222260471 EUDAMED06974222260488 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 Vitality Staining Solution (Eosin-Nigrosin Staining) 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 | 697422226007GQ | 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 ddf27166-0dd5-4ae3-afe8-82122b6e4c1f 61 fields · synced Jul 17, 2026
- EUDAMED f8a6b521-ed84-4efd-b927-e18756d02d74 61 fields · synced May 18, 2026