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Multi drug Rapid Saliva Test
EUDAMEDClass IVD General (EU MDR)
Ref MDD-7**2/MDP-7**3/MDC-7**5
Identity
- Trade Name
- Multi drug Rapid Saliva Test EUDAMED
- Device Name
- Multi drug Rapid Saliva Test(AMP/BZO/BAR/COC/MET/OPI/PCP/PPX/THC/OXY/KET/BUP/COT/EDDP/6-MAM/MDMA/MTD/TML/K2/FYL/TCA/CBD/ALC EUDAMED
- Model / Reference
- MDD-7**2/MDP-7**3/MDC-7**5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-697424646FSH000K2WJ EUDAMED
- Basic UDI-DI
- B-697424646FSH000K2WJ EUDAMED
- EMDN Code
- W0102160511 MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
Multi drug Rapid Saliva Test by Safecare Biotech (Hangzhou) 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-697424646FSH000K2WJ | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Safecare Biotech (hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000019109
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED 34ff81db-0a68-4c8e-ba55-5f769420b40d 61 fields · synced Jun 18, 2026