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Helicobacter pylori nucleic acid real-time PCR detection kit
EUDAMEDClass IVD General (EU MDR)
Ref HP01-2Y32,HP01-1Y32, HP02-Y32Model HP01-2Y32, HP01-1Y32, HP02-Y32
Identity
- Trade Name
- Helicobacter pylori nucleic acid real-time PCR detection kit EUDAMED
- Model / Reference
- HP01-2Y32, HP01-1Y32, HP02-Y32 EUDAMEDHP01-2Y32,HP01-1Y32, HP02-Y32 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974689626339 EUDAMED
- Basic UDI-DI
- B-06974689626339 EUDAMED
- EMDN Code
- W0105090102 H. PYLORI - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Finland 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 nucleic acid real-time PCR detection kit by TargetingOne Technology (Beijing) Corporation — 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-06974689626339 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- TargetingOne Technology (Beijing) Corporation
- EUDAMED SRN
- CN-MF-000028247
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 454a65bf-daf5-46d5-bf23-c85d44ec6afc 61 fields · synced Jun 18, 2026
- EUDAMED 454a65bf-daf5-46d5-bf23-c85d44ec6afc-1 61 fields · synced Jun 10, 2026