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ABON™ Urine Test Drug Screen Cassette
EUDAMEDClass IVD General (EU MDR)
Ref DCO-102Ref DCO-U102Ref DOA-155Ref DBA-102Ref DOA-1125Ref DOA-1104Ref DBZ-102Ref DFT-102Ref DOP-102Ref DMO-102Ref DOA-145Ref DME-U102Ref DOA-135Ref DOA-125
Identity
- Device Name
- ABON™ Urine Test Drug Screen Cassette EUDAMED
- Model / Reference
- DCO-102 EUDAMEDDCO-U102 EUDAMEDDOA-155 EUDAMEDDBA-102 EUDAMEDDOA-1125 EUDAMEDDOA-1104 EUDAMEDDBZ-102 EUDAMEDDFT-102 EUDAMEDDOP-102 EUDAMEDDMO-102 EUDAMEDDOA-145 EUDAMEDDME-U102 EUDAMEDDOA-135 EUDAMEDDOA-125 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952999405653 EUDAMED06952999405677 EUDAMED06952999406063 EUDAMED06952999405608 EUDAMED06952999405875 EUDAMED06952999405837 EUDAMED06952999405622 EUDAMED06952999405707 EUDAMED06952999406148 EUDAMED06952999405776 EUDAMED06952999406001 EUDAMED06952999405752 EUDAMED06952999405950 EUDAMED06952999405912 EUDAMED
- Basic UDI-DI
- B-06952999405653 EUDAMEDB-06952999405677 EUDAMEDB-06952999406063 EUDAMEDB-06952999405608 EUDAMEDB-06952999405875 EUDAMEDB-06952999405837 EUDAMEDB-06952999405622 EUDAMEDB-06952999405707 EUDAMEDB-06952999406148 EUDAMEDB-06952999405776 EUDAMEDB-06952999406001 EUDAMEDB-06952999405752 EUDAMEDB-06952999405950 EUDAMEDB-06952999405912 EUDAMED
- EMDN Code
- W0102160506 COCAINE + COCAINE METABOLITES - RT & POC EUDAMEDW0102160511 MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC EUDAMEDW0102160503 BARBITURATES - RT & POC EUDAMEDW0102160504 BENZODIAZEPINES - RT & POC EUDAMEDW0102160599 DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER EUDAMEDW0102160508 OPIATES - RT & POC EUDAMEDW0102160502 AMPHETAMINE/METHAMPHETAMINE SPECIFIC (+ECSTASY) - 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 Cassette 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-06952999405653 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Abon Biopharm(Hangzhou) Co., Ltd
- EUDAMED SRN
- CN-MF-000009171
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (14)
- EUDAMED 01d37721-7307-4c29-8c3e-788f1373e39a 61 fields · synced Oct 6, 2026
- EUDAMED 918588d4-a6fa-4571-a7ba-dcf701fa94f9 61 fields · synced May 17, 2026
- EUDAMED 02efcfe8-6947-433a-a4a1-ca1e773edcf8 61 fields · synced May 17, 2026
- EUDAMED 08312540-3543-4634-a873-b64c90d320c1 61 fields · synced May 17, 2026
- EUDAMED 5acd392e-d794-4976-b151-eac14c9ec0e7 61 fields · synced May 17, 2026
- EUDAMED b4627f43-52a1-4bc1-9ea0-86347e43e2d6 61 fields · synced May 17, 2026
- EUDAMED a48c5c01-acfd-423b-8fe2-75fb5d147e7c 61 fields · synced May 17, 2026
- EUDAMED e92c15d4-98b7-464f-a0f3-d99105eb2566 61 fields · synced May 18, 2026
- EUDAMED cc141dfc-29e5-436d-8fb7-5752f70969c1 61 fields · synced May 18, 2026
- EUDAMED a2ccf8be-27d6-43bd-9f9f-b07264f60cf2 61 fields · synced May 18, 2026
- EUDAMED 30085288-2d44-41ca-97a4-ccd650a4a896 61 fields · synced May 18, 2026
- EUDAMED d515eceb-546c-41d4-b4ef-9b69a496f7f2 61 fields · synced May 18, 2026
- EUDAMED 2a73850e-b9b7-49dc-8f60-a1931f01a883 61 fields · synced May 18, 2026
- EUDAMED 5dfbf06b-f78a-40bc-9978-3e2f0214957b 61 fields · synced May 19, 2026