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ABON™ Urine Test Drug Screen Strip
EUDAMEDClass IVD General (EU MDR)
Ref DMO-101Ref DMD-101Ref DOP-101Ref DCO-101Ref DCO-U101
Identity
- Device Name
- ABON™ Urine Test Drug Screen Strip EUDAMED
- Model / Reference
- DMO-101 EUDAMEDDMD-101 EUDAMEDDOP-101 EUDAMEDDCO-101 EUDAMEDDCO-U101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952999405769 EUDAMED06952999405721 EUDAMED06952999406131 EUDAMED06952999405646 EUDAMED06952999405660 EUDAMED
- Basic UDI-DI
- B-06952999405769 EUDAMEDB-06952999405721 EUDAMEDB-06952999406131 EUDAMEDB-06952999405646 EUDAMEDB-06952999405660 EUDAMED
- EMDN Code
- W0102160508 OPIATES - RT & POC EUDAMEDW0102160502 AMPHETAMINE/METHAMPHETAMINE SPECIFIC (+ECSTASY) - RT & POC EUDAMEDW0102160506 COCAINE + COCAINE METABOLITES - 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 Drug Screen Strip by Abon Biopharm(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-06952999405769 | 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 (5)
- EUDAMED 801767a7-12c5-4e96-b882-20afed02254c 61 fields · synced Jul 27, 2026
- EUDAMED 870de21f-f924-465c-b8ba-20781f584037 61 fields · synced May 17, 2026
- EUDAMED 75ae39e4-c5cb-4159-a69e-70f185021329 61 fields · synced May 17, 2026
- EUDAMED 8dd02090-1a83-4e78-be0b-f04b9944a47c 61 fields · synced May 17, 2026
- EUDAMED 934e61b7-6919-42a1-92b0-17d64f62e9be 61 fields · synced May 18, 2026