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VivaDiag Rotavirus/Adenovirus Test Kit (FIA)

EUDAMED

Class IVD General (EU MDR)

Ref VID112-01-011Model VID112Ref VID123-01-011Model VID123

by VivaChek Biotech (Hangzhou) Co., Ltd.

Identity

Trade Name
VivaDiag Rotavirus/Adenovirus Test Kit (FIA) EUDAMED
Rotavirus Test Kit (FIA) EUDAMED
Device Name
VivaDiag Rotavirus/Adenovirus Test Kit (FIA) EUDAMED
Rotavirus Test Kit (FIA) EUDAMED
Model / Reference
VID112 EUDAMED
VID112-01-011 EUDAMED
VID123 EUDAMED
VID123-01-011 EUDAMED

Identifiers

Primary DI / UDI-DI
06937339205063 EUDAMED
D-VID112EL EUDAMED
06937339206756 EUDAMED
Basic UDI-DI
B-06937339205063 EUDAMED
B-VID112EL EUDAMED
B-06937339206756 EUDAMED
EMDN Code
W0105040699 VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER EUDAMED
W0105040606 ROTAVIRUS EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Italy EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

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

VivaDiag Rotavirus/Adenovirus Test Kit (FIA) by VivaChek Biotech (Hangzhou) Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
VivaChek Biotech (Hangzhou) Co., Ltd.
EUDAMED SRN
CN-MF-000012160
Authorised Representative
Lotus NL B.V. NL-AR-000000121

Sources (3)

  • EUDAMED 8a03be5e-13e7-45e9-b0e8-8381a4fe00ab 61 fields · synced Oct 9, 2026
  • EUDAMED 060c5289-8e38-4cf2-b918-b486fc1117b5 61 fields · synced May 17, 2026
  • EUDAMED e5b99c8c-f7f2-4513-8078-accd92736fd0 61 fields · synced Jun 18, 2026