HEV IgM Rapid Test
by Hangzhou Alltest Biotech.Co., Ltd.
Ref IHEM-302
HEV IgM Rapid Test (IHEM-302) is a device classified as IVD General made by Hangzhou Alltest Biotech.Co., Ltd., registered in EUDAMED on 21 Sep 2026 (Basic UDI-DI B-IHEM-302(AT)EW), active as of 24 Oct 2026.
Active
CE IVDD
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-IHEM-302(AT)EW | Date21 Sep 2026 | StatusActive |
Official records
- EUDAMED public site B-IHEM-302(AT)EW
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD Active
Specification
- Model / reference
- IHEM-302
- Primary DI / UDI-DI
- D-IHEM-302(AT)EW, D-IHEM-302DN
- Basic UDI-DI
- B-IHEM-302(AT)EW, B-IHEM-302DN
- EMDN code
- W0105099099, W0105020505
- Device class
- Class IVD General
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- GermanySpain
Manufacturer details
- EUDAMED SRN
- CN-MF-000010710
- Authorised representative
- VidaQuick Biotech S.L. ES-AR-000048138
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