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ABON™ Urine Test E-Z Split Key™ Drug Screen Cup
EUDAMEDClass IVD General (EU MDR)
Ref DBO-1127Ref DBD-1107Ref DBD-157Ref DBO-157Ref DBD-137Ref DBD-167
Identity
- Device Name
- ABON™ Urine Test E-Z Split Key™ Drug Screen Cup EUDAMED
- Model / Reference
- DBO-1127 EUDAMEDDBD-1107 EUDAMEDDBD-157 EUDAMEDDBO-157 EUDAMEDDBD-137 EUDAMEDDBD-167 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952999405509 EUDAMED06952999405356 EUDAMED06952999405417 EUDAMED06952999405400 EUDAMED06952999405530 EUDAMED06952999405523 EUDAMED06952999405387 EUDAMED06952999405424 EUDAMED06952999405363 EUDAMED06952999405349 EUDAMED
- Basic UDI-DI
- B-06952999405509 EUDAMEDB-06952999405356 EUDAMEDB-06952999405417 EUDAMEDB-06952999405400 EUDAMEDB-06952999405530 EUDAMEDB-06952999405523 EUDAMEDB-06952999405387 EUDAMEDB-06952999405424 EUDAMEDB-06952999405363 EUDAMEDB-06952999405349 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-06952999405509 | 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 (10)
- EUDAMED 7f83b40c-d781-44f8-9b3b-c3be34fe4e8c 61 fields · synced Jul 29, 2026
- EUDAMED 69e61c77-5416-46c0-9a01-3816895fd345 61 fields · synced May 16, 2026
- EUDAMED 718f53d4-c45e-434e-9524-fc24af7ce445 61 fields · synced May 16, 2026
- EUDAMED 75686217-efb2-41f8-acad-42085f41fdfa 61 fields · synced May 17, 2026
- EUDAMED a7cf6305-b356-4d12-927b-0ef6ce159e20 61 fields · synced May 17, 2026
- EUDAMED ce1580e3-a112-4924-b580-4f65a977a661 61 fields · synced May 17, 2026
- EUDAMED 59119b46-8b44-4260-bcc1-5140af108a98 61 fields · synced May 18, 2026
- EUDAMED e832b1d5-f21e-4f3d-8504-6a795ab74d74 61 fields · synced May 19, 2026
- EUDAMED 6170a46a-1c0d-4daa-a95e-14c02b3c3e73 61 fields · synced May 19, 2026
- EUDAMED e78041d0-f8e5-4c04-ac1f-2efeb212b132 61 fields · synced May 19, 2026