Identity
- Device Name
- COVID-19 test kits EUDAMED
- Model / Reference
- 123456 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-T0001RH EUDAMED
- Basic UDI-DI
- B-T0001RH EUDAMED
- EMDN Code
- Z12040299 GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
Yes
EUDAMED
Surgical Instrument
No
EUDAMED
Category: Dermatological laser beam guiding handpiece
COVID-19 test kits by Shanghai Shankou Trading Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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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-T0001RH | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shanghai Shankou Trading Co., Ltd.
- EUDAMED SRN
- CN-MF-000052481
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED 1eb395c3-b1a1-48c1-8623-43cee4b77cb5 61 fields · synced Jun 20, 2026