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Group B Streptococcus Nucleic Acid Detection Kit (Real-Time PCR)
EUDAMEDClass IVD General (EU MDR)
Ref 213601
Identity
- Trade Name
- Group B Streptococcus Nucleic Acid Detection Kit (Real-Time PCR) EUDAMED
- Device Name
- Group B Streptococcus Nucleic Acid Detection Kit (Real-Time PCR) EUDAMED
- Model / Reference
- 213601 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955931305226 EUDAMED06955931305240 EUDAMED
- Basic UDI-DI
- B-06955931305226 EUDAMEDB-06955931305240 EUDAMED
- EMDN Code
- W0105011104 STREP. B DETECTION BY NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
Group B Streptococcus Nucleic Acid Detection Kit (Real-Time PCR) by Yaneng BIOscience (Shenzhen) Co., Ltd. — 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-06955931305226 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Yaneng BIOscience (Shenzhen) Co., Ltd.
- EUDAMED SRN
- CN-MF-000013666
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED a1e38ee5-225b-4724-9ada-9bef05c832cf 61 fields · synced Jul 27, 2026
- EUDAMED 4d871dcc-5b3b-4e18-937f-680c327627e4 61 fields · synced May 19, 2026