Identity
- Trade Name
- Rapid HEV IgG/IgM Combo Test Card EUDAMED
- Device Name
- Rapid HEV IgG/IgM Combo Test Card EUDAMED
- Model / Reference
- 1H26C2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06921963717115 EUDAMED
- Basic UDI-DI
- B-06921963717115 EUDAMED
- EMDN Code
- W0105099099 VIROLOGY - RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
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
Rapid HEV IgG/IgM Combo Test Card by Xiamen Boson Biotech Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06921963717115 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Xiamen Boson Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000001096
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 0501b43a-906c-4f50-b49b-69e7bcbb8d13 61 fields · synced Jul 9, 2026