← Back to catalogue
Helicobacter Pylori Analyzer
EUDAMEDClass IVD General (EU MDR)
Ref FR-9101Ref FR-9202
Identity
- Trade Name
- Helicobacter Pylori Analyzer EUDAMED
- Device Name
- Helicobacter Pylori Analyzer EUDAMED
- Model / Reference
- FR-9101 EUDAMEDFR-9202 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976093859112 EUDAMED06976093859228 EUDAMED
- Basic UDI-DI
- B-06976093859112 EUDAMEDB-06976093859228 EUDAMED
- EMDN Code
- W0299 IVD INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
Helicobacter Pylori Analyzer by Badiusen Biotechnology (Kunshan) 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-06976093859112 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Badiusen Biotechnology (Kunshan) Co., Ltd
- EUDAMED SRN
- CN-MF-000032909
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (2)
- EUDAMED 72653041-f6ce-4a8f-bc16-181e436ee5a9 61 fields · synced Jul 12, 2026
- EUDAMED 16090f7a-bb3f-4eaf-ada3-860b657e478c 61 fields · synced May 18, 2026