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Group A Streptococcus (GAS) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probi…
EUDAMEDClass IVD General (EU MDR)
Ref S3260E-24Ref S3260E-48
Identity
- Device Name
- Group A Streptococcus (GAS) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) EUDAMED
- Model / Reference
- S3260E-24 EUDAMEDS3260E-48 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792735569 EUDAMED06955792735576 EUDAMED
- Basic UDI-DI
- B-06955792735569 EUDAMEDB-06955792735576 EUDAMED
- EMDN Code
- W0105011103 STREP. A DETECTION BY NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
Group A Streptococcus (GAS) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probi… by Sansure Biotech Inc. — 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-06955792735569 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Sansure Biotech Inc.
- EUDAMED SRN
- CN-MF-000011392
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED b8d2d5f8-1165-4ed1-a1a8-0d8c481f4d0d 61 fields · synced Jul 14, 2026
- EUDAMED 4a697865-dbaa-4e5b-bb9e-d421cec58f20 61 fields · synced May 17, 2026