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Vaginitis Multitest Kit（Enzyme Reaction）
EUDAMEDClass IVD General (EU MDR)
Ref /Model RT-F600AModel F-8A
Identity
- Device Name
- Vaginitis Multitest Kit（Enzyme Reaction） EUDAMED
- Model / Reference
- RT-F600A EUDAMED/ EUDAMEDF-8A EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-90101-016Y EUDAMEDD-90102GS EUDAMED
- Basic UDI-DI
- B-90101-016Y EUDAMEDB-90102GS EUDAMED
- EMDN Code
- W0101060401 MULTIPLE ENZYMES &/OR SUBSTRATES &/OR ELECTROLYTES EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy 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
Vaginitis Multitest Kit（Enzyme Reaction） by Shenzhen Reetoo Biotechnology Co., Ltd — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-90101-016Y | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Reetoo Biotechnology Co., Ltd
- EUDAMED SRN
- CN-MF-000011699
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 19453631-c7a6-441d-8d6e-57cdd59a9332 61 fields · synced Jul 9, 2026
- EUDAMED b919e6fd-28bf-42e0-9a50-4a5c170d511a 61 fields · synced May 19, 2026