Identity
- Trade Name
- LYHER EUDAMED
- Device Name
- Respiratory multiple 4 in 1 test kit (FluA/FluB/COVID-19/RSV) EUDAMED
- Model / Reference
- 303021901 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972412614943 EUDAMED
- Basic UDI-DI
- 0697241261IRS-542BF EUDAMED
- EMDN Code
- W0105090699 OTHER MULTIPLE PATHOGENS - RT & POC EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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
New Device
No
EUDAMED
Lyher by Hangzhou Laihe Biotech Co., Ltd. — 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 | 0697241261IRS-542BF | Class B | Active |
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Manufacturer
- Manufacturer
- Hangzhou Laihe Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000033566
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 4d6b905b-be32-4ab2-ba4e-0e5538fbbc8f 61 fields · synced May 23, 2026