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OnSite® H. pylori Ag Rapid Test
EUDAMEDClass B (EU MDR)
Ref R0192C-30TModel R0192C
Identity
- Trade Name
- OnSite® H. pylori Ag Rapid Test EUDAMED
- Device Name
- H. Pylori Ag Rapid Test EUDAMED
- Model / Reference
- R0192C EUDAMEDR0192C-30T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810114460993 EUDAMED
- Basic UDI-DI
- 081011446R0192CEF EUDAMED
- EMDN Code
- W0105010401 H. PYLORI ANTIGEN DETECTION EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
OnSite® H. pylori Ag Rapid Test by Ctk Biotech, Inc. — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 081011446R0192CEF | Class B | Active |
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Manufacturer
- Manufacturer
- CTK Biotech Inc.
- EUDAMED SRN
- US-MF-000024900
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 7784af47-8b40-40b6-a86d-08fa14ea9a11 61 fields · synced Jul 29, 2026