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QuikRead go Strep A
EUDAMEDClass IVD General (EU MDR)
Ref 135883Ref 155464
by Aidian Oy
Identity
- Trade Name
- QuikRead go Strep A EUDAMEDQuikRead go Strep A Extraction Tubes EUDAMED
- Device Name
- QuikRead go Strep A EUDAMEDQuikRead go Strep A Extraction Tubes EUDAMED
- Model / Reference
- 135883 EUDAMED155464 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438115001034 EUDAMED06438115001737 EUDAMED
- Basic UDI-DI
- B-06438115001034 EUDAMED6438115QRgoStrepAExtTubQD EUDAMED
- EMDN Code
- W0105090103 STREP. A - RT & POC EUDAMEDW05020103 SAMPLES TRANSPORT, BOTTLES EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass A EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMEDEUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMEDEUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
QuikRead go Strep A by Aidian Oy — Class IVD General — IVDR, IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06438115001034 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06438115001034 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Aidian Oy
- EUDAMED SRN
- FI-MF-000023611
Sources (2)
- EUDAMED 8d360dde-3477-4c93-835c-1c98859b6e18 61 fields · synced Jul 18, 2026
- EUDAMED c622327c-fffb-4a70-ab6b-71a615d01b0e 61 fields · synced May 17, 2026