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Multiple Real-Time PCR Detection Kit for Helicobacter Pylori Resistance Gene
EUDAMEDClass IVD General (EU MDR)
Ref CT8233-48TRef CT8233-24T
Identity
- Device Name
- Multiple Real-Time PCR Detection Kit for Helicobacter Pylori Resistance Gene EUDAMED
- Model / Reference
- CT8233-48T EUDAMEDCT8233-24T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974323012306 EUDAMED06974323012290 EUDAMED
- Basic UDI-DI
- B-06974323012306 EUDAMEDB-06974323012290 EUDAMED
- EMDN Code
- W0105010499 H. PYLORI REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General 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
Multiple Real-Time PCR Detection Kit for Helicobacter Pylori Resistance Gene by Beijing Applied Biological Technologies Co., Ltd. — Class IVD General — IVDD…
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-06974323012306 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Beijing Applied Biological Technologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000012338
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (2)
- EUDAMED 258086e5-a74e-4387-9a2b-576ef2d4b54d 61 fields · synced Aug 2, 2026
- EUDAMED 5539ca06-fea9-4e3c-9c47-0605a0a24cfc 61 fields · synced May 18, 2026