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Accu-Tell® Urine Reagent Strips 1Para
EUDAMEDClass IVD General (EU MDR)
Ref ABT-UM-A42Model StripRef ABT-UM-A243Ref ABT-UM-A253Ref ABT-UM-A252Ref ABT-UM-A36GW
Identity
- Trade Name
- Accu-Tell® Urine Reagent Strips 1Para EUDAMED
- Device Name
- Accu-Tell® Urine Reagent Strips EUDAMED
- Model / Reference
- Strip EUDAMEDABT-UM-A42 EUDAMEDABT-UM-A243 EUDAMEDABT-UM-A253 EUDAMEDABT-UM-A252 EUDAMEDABT-UM-A36GW EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970581430654 EUDAMED06970581430685 EUDAMED06970581430678 EUDAMED06970581430661 EUDAMED06970581430807 EUDAMED
- Basic UDI-DI
- B-06970581430654 EUDAMEDB-06970581430685 EUDAMEDB-06970581430678 EUDAMEDB-06970581430661 EUDAMEDB-06970581430807 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 1Para 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-06970581430654 | 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 52b9cca4-4dd8-438b-b5c5-7e0299f24378 61 fields · synced Jul 19, 2026
- EUDAMED 9ff3104a-e8f8-43c8-b0f9-108305b6016d 61 fields · synced May 16, 2026
- EUDAMED 462e05b1-ec15-49ad-a6eb-60c91a580145 61 fields · synced May 17, 2026
- EUDAMED a237dc61-9be9-44d5-9b2a-528359e1f9f1 61 fields · synced May 18, 2026
- EUDAMED 19de332e-4738-4bc2-9530-b5050d4850e2 61 fields · synced May 18, 2026