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Multi drug Rapid Urine Test
EUDAMEDClass IVD General (EU MDR)
Ref MDD-1xx2/MDP-1xx4/MDC-1xx5
Identity
- Trade Name
- Multi drug Rapid Urine Test EUDAMED
- Device Name
- Multi drug Rapid Urine Test(AMP/THC/COC/PCP/OPI/MOR/MET/MTD/BAR/BZO/TCA/MDMA/BUP/EDDP/PPX/ ETG/K2/TML/MQL/COT/FYL/OXY/KET/KRA/LSD/CBD/ETO/PGB/GHB/6-MAM/ COD/MDPV/MPD/ZAL/ZOP/GAB/ACE/MCAT/SOMA/MDA/ZOL/Alfa-PVP/MEP/TPM/ALC/OXI/SG/PH/NIT/GLU/CRE) EUDAMED
- Model / Reference
- MDD-1xx2/MDP-1xx4/MDC-1xx5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-697424646MDOAU0018J82 EUDAMED
- Basic UDI-DI
- B-697424646MDOAU0018J82 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 Urine 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-697424646MDOAU0018J82 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Safecare Biotech (hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000019109
- Authorised Representative
- UnicareQ GmbH DE-AR-000051497
Sources (1)
- EUDAMED c2c5cde2-d6bf-41ec-bda8-c209cee7ccc5 61 fields · synced Oct 6, 2026