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Double fluorescence staining solution
EUDAMEDClass A (EU MDR)
Ref 18-05-0028Model 50 Tests/box
Identity
- Device Name
- Double fluorescence staining solution EUDAMED
- Model / Reference
- 50 Tests/box EUDAMED18-05-0028 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974674895931 EUDAMED
- Basic UDI-DI
- 69746748900174A2 EUDAMED
- EMDN Code
- W01030708 STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain 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
Double fluorescence staining solution by Shenzhen Zijian Biotechnology Co., Ltd — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 69746748900174A2 | Class A | Active |
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Manufacturer
- Manufacturer
- Shenzhen Zijian Biotechnology Co., Ltd
- EUDAMED SRN
- CN-MF-000022829
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 9df9467d-e261-4567-85ce-be8e30d4a149 61 fields · synced Oct 6, 2026