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Drugs Screen Card
EUDAMEDClass IVD General (EU MDR)
Ref DOA-10Ref DOA-2Ref DOA-2CT
Identity
- Trade Name
- Drugs Screen Card EUDAMED
- Device Name
- Drug screen card EUDAMEDDrugs Screen Card EUDAMED
- Model / Reference
- DOA-10 EUDAMEDDOA-2 EUDAMEDDOA-2CT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05404035101179 EUDAMED05404035101186 EUDAMED05404035101193 EUDAMED
- Basic UDI-DI
- B-05404035101179 EUDAMEDB-05404035101186 EUDAMEDB-05404035101193 EUDAMED
- EMDN Code
- W0102090101,W0102090102,W0102090103,W0102090104,W0102090105,W0102090106,W0102090110,W0102090112,W0102090114,W0102090119 EUDAMEDW0102090105,W0102090112 EUDAMEDW0102090105,W0102090106 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Belgium 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
Drugs Screen Card by Cypress Diagnostics — 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-05404035101179 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Cypress Diagnostics
- EUDAMED SRN
- BE-MF-000000033
Sources (3)
- EUDAMED 9e0c1fc7-b489-4cb8-917c-528879f0c421 61 fields · synced Sep 17, 2026
- EUDAMED ed49e7c9-3224-4e96-a19c-93397d06fd8c 61 fields · synced May 16, 2026
- EUDAMED 9e7ab95a-2ed9-432c-abc7-4cee497ee5f5 61 fields · synced May 18, 2026