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Fungal fluorescence staining solution
EUDAMEDClass A (EU MDR)
Ref 18-05-0030Model 50 Tests/boxRef 18-05-0029Ref 18-05-0031
Identity
- Device Name
- Fungal fluorescence staining solution EUDAMED
- Model / Reference
- 50 Tests/box EUDAMED18-05-0030 EUDAMED18-05-0029 EUDAMED18-05-0031 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974674895955 EUDAMED06974674895948 EUDAMED06974674895962 EUDAMED
- Basic UDI-DI
- 69746748900175A4 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
Fungal 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 | 69746748900175A4 | 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 (3)
- EUDAMED fb6f8bc7-c48b-4cfb-9abd-f3cc30ec7b13 61 fields · synced Oct 5, 2026
- EUDAMED 26b78277-b060-4362-9f41-366868d84d43 61 fields · synced May 18, 2026
- EUDAMED cdb8c504-f2e9-4fa0-9c72-fbf1e68d5fe0 61 fields · synced May 18, 2026