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Group B Streptococcus DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)
EUDAMEDClass C (EU MDR)
Ref S3056E-24
Identity
- Device Name
- Group B Streptococcus DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) EUDAMED
- Model / Reference
- S3056E-24 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792700895 EUDAMED
- Basic UDI-DI
- 69557927S3056E000001S7 EUDAMED
- EMDN Code
- W0105011104 STREP. B DETECTION BY NA REAGENTS EUDAMED
Classification
- Device Class
- Class C 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
New Device
No
EUDAMED
Group B Streptococcus DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) by Sansure Biotech Inc. — Class C — IVDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 69557927S3056E000001S7 | Class C | 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 46d8b8c6-d60b-4180-8cd7-3e8449e4f5e2 61 fields · synced Jun 18, 2026
- EUDAMED e3c0dffc-7adc-4e4b-a7e1-b057a84a5af7 61 fields · synced Jun 18, 2026