Identity
- Trade Name
- OnSite® RSV Ag Rapid Test EUDAMED
- Device Name
- RSV Ag Rapid Test EUDAMED
- Model / Reference
- R0186C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00855402007597 EUDAMED
- Basic UDI-DI
- 081011446R0186CEN EUDAMED
- EMDN Code
- W0105099002 RSV - RT & POC 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® RSV 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 | 081011446R0186CEN | Class B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- CTK Biotech Inc.
- EUDAMED SRN
- US-MF-000024900
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 38065fab-bcc5-48a0-a7ec-8550c7ffe6aa 61 fields · synced Jun 18, 2026