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One Step Strep A Swab Test
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref W039P0001Ref W39-SH
Identity
- Device Name
- One Step Strep A Swab Test EUDAMED
- Model / Reference
- W039P0001 EUDAMEDW39-SH EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-W039P0001N5 EUDAMEDD-W39-SH9D EUDAMED
- Basic UDI-DI
- B-W039P0001N5 EUDAMEDB-W39-SH9D EUDAMED
- EMDN Code
- W0105090103 STREP. A - RT & POC EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
One Step Strep A Swab Test by Guangzhou Wondfo Biotech Co., Ltd. — Class IVD devices for self-testing — 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-W039P0001N5 | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- Guangzhou Wondfo Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000000689
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (2)
- EUDAMED a0a71ee8-82bc-4154-b72d-f81e7fc52a0a 61 fields · synced Jul 19, 2026
- EUDAMED f5ed3733-2d2e-47b2-a8aa-6c1400b93779 61 fields · synced May 19, 2026