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David
EUDAMEDClass IVD General (EU MDR)
Ref RH-COC-S, RH-COC-CModel strip, cassetteRef RH-THC-S, RH-THC-CRef RH-MOPRef RH-MET-S, RH-MET-CRef RH-MOP/MET-C, RH-MOP/MET-P, RH-MOP/MET-CPModel dipcard, cassette and cupRef RH-MOP/MET/KET-C, RH-MOP/MET/KET-P, RH-MOP/MET/KET-CP
Identity
- Trade Name
- DAVID EUDAMED
- Device Name
- One Step COC Screen Test (Urine) EUDAMEDOne Step THC Screen Test (Urine) EUDAMEDOne Step MOP Screen Test (Urine) EUDAMEDOne Step MET Screen Test (Urine) EUDAMEDOne Step MOP/MET Screen Test (Urine) EUDAMEDOne Step MOP/MET/KET Screen Test (Urine) EUDAMED
- Model / Reference
- strip, cassette EUDAMEDRH-COC-S, RH-COC-C EUDAMEDRH-THC-S, RH-THC-C EUDAMEDRH-MOP EUDAMEDRH-MET-S, RH-MET-C EUDAMEDdipcard, cassette and cup EUDAMEDRH-MOP/MET-C, RH-MOP/MET-P, RH-MOP/MET-CP EUDAMEDRH-MOP/MET/KET-C, RH-MOP/MET/KET-P, RH-MOP/MET/KET-CP EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-69384449COC01RZ EUDAMEDD-69384449THC01WB EUDAMEDD-69384449MOP01XG EUDAMEDD-69384449MET01VW EUDAMEDD-69384449MOP/MET01W3 EUDAMEDD-69384449MOP/MET/KET014R EUDAMED
- Basic UDI-DI
- B-69384449COC01RZ EUDAMEDB-69384449THC01WB EUDAMEDB-69384449MOP01XG EUDAMEDB-69384449MET01VW EUDAMEDB-69384449MOP/MET01W3 EUDAMEDB-69384449MOP/MET/KET014R EUDAMED
- EMDN Code
- W0102160506 COCAINE + COCAINE METABOLITES - RT & POC EUDAMEDW0102160599 DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER EUDAMEDW0102160511 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
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
David by Equinox Biotech 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-69384449COC01RZ | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Equinox Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000018901
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (10)
- EUDAMED df21916d-da7c-4de4-aa54-d7e390d91136 61 fields · synced Jul 31, 2026
- EUDAMED 945b9f55-60bd-4f98-b83f-b9530118bca1 61 fields · synced May 17, 2026
- EUDAMED b9dd7b36-04c8-415d-9d98-4980782b22b4 61 fields · synced May 17, 2026
- EUDAMED 27636785-ec2a-42a5-ad60-d66dd3c79d43 61 fields · synced May 18, 2026
- EUDAMED 3831fa55-65f5-4514-a542-ce5fbd3beb3b 61 fields · synced May 18, 2026
- EUDAMED 82d44eba-93ea-4b32-942d-783e474c9943 61 fields · synced May 18, 2026
- EUDAMED 3831fa55-65f5-4514-a542-ce5fbd3beb3b-1 61 fields · synced Jul 10, 2026
- EUDAMED df21916d-da7c-4de4-aa54-d7e390d91136-1 61 fields · synced Jul 10, 2026
- EUDAMED 82d44eba-93ea-4b32-942d-783e474c9943-1 61 fields · synced Jul 14, 2026
- EUDAMED 27636785-ec2a-42a5-ad60-d66dd3c79d43-1 61 fields · synced Jul 31, 2026