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Accu-Tell® Urine Reagent Strips 2Para
EUDAMEDClass IVD General (EU MDR)
Ref ABT-UM-A334Model StripRef ABT-UM-A38Ref ABT-UM-A38GWRef ABT-UM-A37Ref ABT-UM-A37KW
Identity
- Trade Name
- Accu-Tell® Urine Reagent Strips 2Para EUDAMED
- Device Name
- Accu-Tell® Urine Reagent Strips EUDAMED
- Model / Reference
- Strip EUDAMEDABT-UM-A334 EUDAMEDABT-UM-A38 EUDAMEDABT-UM-A38GW EUDAMEDABT-UM-A37 EUDAMEDABT-UM-A37KW EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970581430715 EUDAMED06970581430708 EUDAMED06970581430791 EUDAMED06970581430692 EUDAMED06970581430784 EUDAMED
- Basic UDI-DI
- B-06970581430715 EUDAMEDB-06970581430708 EUDAMEDB-06970581430791 EUDAMEDB-06970581430692 EUDAMEDB-06970581430784 EUDAMED
- EMDN Code
- W0101060204 URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
Accu-Tell® Urine Reagent Strips 2Para by AccuBioTech 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-06970581430715 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- AccuBioTech Co., Ltd.
- EUDAMED SRN
- CN-MF-000025172
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (5)
- EUDAMED ff864f8e-6253-440e-bb56-d286d8e84388 61 fields · synced Oct 6, 2026
- EUDAMED ba38bf05-422c-49ba-9095-886992c81e42 61 fields · synced May 18, 2026
- EUDAMED 6f9135a0-c955-41c9-9aae-61e6a7992069 61 fields · synced May 18, 2026
- EUDAMED 27b5801a-80e6-4517-8dd8-81fb9a5fb32f 61 fields · synced May 19, 2026
- EUDAMED 845560af-2511-47bb-b937-bb5832d8f587 61 fields · synced May 19, 2026