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STD3 Real-time PCR Kit
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref HBRT-STD3: CT/NG/UUModel 6 Tests/KitModel 48 Tests/Kit
Identity
- Trade Name
- STD3 Real-time PCR Kit EUDAMED
- Device Name
- STD3 Real-time PCR Kit EUDAMED
- Model / Reference
- HBRT-STD3: CT/NG/UU EUDAMED6 Tests/Kit EUDAMED48 Tests/Kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971532200135 EUDAMED06971532200418 EUDAMED
- Basic UDI-DI
- B-06971532200135 EUDAMEDB-06971532200418 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 Annex II List B EUDAMED
- Market of Registration
- Germany 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
STD3 Real-time PCR Kit by Guangzhou Hybribio Medicine Technology Ltd. — Class IVD Annex II List B — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Unknown
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06971532200135 | Class IVD Annex II List B | Unknown |
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Manufacturer
- Manufacturer
- Guangzhou Hybribio Medicine Technology Ltd.
- EUDAMED SRN
- CN-MF-000027677
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (3)
- EUDAMED 596e2eab-612d-4417-a4a2-bc308d082e0a 61 fields · synced Jul 11, 2026
- EUDAMED 1dedb802-37a1-4c09-bc72-6109f0adf7f5 61 fields · synced Jul 10, 2026
- EUDAMED 30be6640-b7cb-4c91-b38f-048dbe217210 61 fields · synced Jul 11, 2026