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Eight Respiratory Pathogen Antigen Rapid Test Kit (LFIA)
EUDAMEDClass C (EU MDR)
Ref 123145-05-102Model 123145-01-102 123145-02-102 123145-05-102 123145-20-102
Identity
- Device Name
- Eight Respiratory Pathogen Antigen Rapid Test Kit (LFIA) EUDAMED
- Model / Reference
- 123145-01-102 123145-02-102 123145-05-102 123145-20-102 EUDAMED123145-05-102 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974167892164 EUDAMED
- Basic UDI-DI
- 697416789123145ZT EUDAMED
- Direct Marketing DI
- 06974167892164 EUDAMED
- EMDN Code
- W0105099099 VIROLOGY - RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Eight Respiratory Pathogen Antigen Rapid Test Kit (LFIA) by Jiangsu Medomics Medical Technology Co., Ltd. — Class C — IVDR — listed in EUDAMED
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 | 697416789123145ZT | Class C | Active |
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Manufacturer
- Manufacturer
- Jiangsu Medomics Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000030226
- Authorised Representative
- Mega Eurostar Sp. z o.o. PL-AR-000042730
Sources (1)
- EUDAMED 36a9c5e0-199d-44a5-b59c-440316fa11f2 61 fields · synced Jul 18, 2026