← Back to catalogue
GBS Real-time PCR Kit
EUDAMEDClass IVD General (EU MDR)
Ref HBRT-GBSModel 6 tests/kit
Identity
- Device Name
- GBS Real-time PCR Kit EUDAMED
- Model / Reference
- 6 tests/kit EUDAMEDHBRT-GBS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942221702209 EUDAMED
- Basic UDI-DI
- B-06942221702209 EUDAMED
- EMDN Code
- W0105011104 STREP. B DETECTION BY NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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
GBS Real-time PCR Kit by Chaozhou Hybribio Biochemistry Ltd. — Class IVD General — 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-06942221702209 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Chaozhou Hybribio Biochemistry Ltd.
- EUDAMED SRN
- CN-MF-000023818
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (1)
- EUDAMED a7886b8d-c7e8-40f3-810b-84caadf10566 61 fields · synced Jul 30, 2026