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Helicobacter Pylori Real Time PCR Kit
EUDAMEDClass IVD General (EU MDR)
Ref SD-0354-02
Identity
- Trade Name
- Helicobacter Pylori Real Time PCR Kit EUDAMED
- Device Name
- Helicobacter Pylori Real Time PCR Kit EUDAMED
- Model / Reference
- SD-0354-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971042229527 EUDAMED
- Basic UDI-DI
- B-06971042229527 EUDAMED
- EMDN Code
- W0105010403 H. PYLORI DETECTION BY NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France 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
Helicobacter Pylori Real Time PCR Kit by Shanghai Zj Bio-Tech Co., 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-06971042229527 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shanghai Zj Bio-Tech Co., Ltd
- EUDAMED SRN
- CN-MF-000017861
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED 12d0764e-7dfa-4e13-b224-2c2862949562 61 fields · synced Jul 10, 2026