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ABON™ Urine Test E-Z Split Key™ Drug Screen Cup
EUDAMEDClass IVD General (EU MDR)
Ref DBD-127
Identity
- Device Name
- ABON™ Urine Test E-Z Split Key™ Drug Screen Cup EUDAMED
- Model / Reference
- DBD-127 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952999405370 EUDAMED
- Basic UDI-DI
- B-06952999405370 EUDAMED
- EMDN Code
- W0102160511 MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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
ABON™ Urine Test E-Z Split Key™ Drug Screen Cup by Abon Biopharm(Hangzhou) Co., Ltd — Class IVD General — IVDD — listed in EUDAMED
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-06952999405370 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Abon Biopharm(Hangzhou) Co., Ltd
- EUDAMED SRN
- CN-MF-000009171
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED 56306c88-68e2-4668-aa38-ae9a46f782fa 61 fields · synced Jun 18, 2026