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STD2 Real-time PCR Kit
EUDAMEDClass IVD General (EU MDR)
Ref HBRT-STD2/MModel 48 tests/kit
Identity
- Device Name
- STD2 Real-time PCR Kit EUDAMED
- Model / Reference
- 48 tests/kit EUDAMEDHBRT-STD2/M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942221704661 EUDAMED
- Basic UDI-DI
- B-06942221704661 EUDAMED
- EMDN Code
- W0105070501 STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain 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
STD2 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-06942221704661 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Chaozhou Hybribio Biochemistry Ltd.
- EUDAMED SRN
- CN-MF-000023818
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED 8f6aabd5-9453-479f-b506-62420ff47d15 61 fields · synced Jul 19, 2026