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Bio·Firm

EUDAMED

Class IVD General (EU MDR)

Ref WI-MICR-C43A-25Ref WI-MPXV-C42-25Ref WW-SP-C91-25Ref WI-MICR-C83A-01Ref WI-MICR-C810C-01Ref WI-MICR-C86A-25Ref WI-GON-C71-25Ref WI-FLU-C82-25Ref WI-MICR-C83A-25Ref WI-MICR-C43A-10Ref WI-MICR-C85A-25Ref WD-MET-C11A-25Ref WO-VD-C41-25

by Zhejiang Wantaifu Biotechnology Co., Ltd

Identity

Trade Name
Bio·Firm EUDAMED
Bio-Firm EUDAMED
Device Name
Dengue IgG/IgM and NS1 Rapid Test Device EUDAMED
Monkeypox Virus IgG/IgM Rapid Test Device (Whole Blood/Serum/Plasma) EUDAMED
Sperm SP10 protein detection device EUDAMED
SARS-CoV-2&Influenza AB Antigen Combo Rapid Test Kit (LFIA） EUDAMED
FLU A/B & SARS-Cov-2 & RSV& ADV &PIV I/III &PIV II &MP & HMV & HRV Combo Rapid Test Device EUDAMED
FLU A/B & SARS-Cov-2 & RSV& ADV & MP Combo Rapid Test Device EUDAMED
Gonorrhea Rapid Test EUDAMED
Influenza A+B Rapid Test Cassette EUDAMED
SARS-CoV-2 & Influenza AB Antigen Combo Rapid Test Kit (LFIA) EUDAMED
FLU A & B & SARS-Cov-2 & RSV& ADV Combo Rapid Test Device EUDAMED
MET Rapid Test Device (Urine) EUDAMED
Vitamin D Rapid Test Cassette EUDAMED
Model / Reference
WI-MICR-C43A-25 EUDAMED
WI-MPXV-C42-25 EUDAMED
WW-SP-C91-25 EUDAMED
WI-MICR-C83A-01 EUDAMED
WI-MICR-C810C-01 EUDAMED
WI-MICR-C86A-25 EUDAMED
WI-GON-C71-25 EUDAMED
WI-FLU-C82-25 EUDAMED
WI-MICR-C83A-25 EUDAMED
WI-MICR-C43A-10 EUDAMED
WI-MICR-C85A-25 EUDAMED
WD-MET-C11A-25 EUDAMED
WO-VD-C41-25 EUDAMED

Identifiers

Primary DI / UDI-DI
D-WI-MICR-C43A-25A3 EUDAMED
D-WI-MPXV-C42-25L6 EUDAMED
D-WW-SP-C91-25LK EUDAMED
06976477340137 EUDAMED
D-WI-MICR-C810C-01TP EUDAMED
D-WI-MICR-C86A-25CQ EUDAMED
D-WI-GON-C71-25FZ EUDAMED
D-WI-FLU-C82-25HN EUDAMED
D-WI-MICR-C83A-25BP EUDAMED
D-WI-MICR-C43A-109N EUDAMED
D-WI-MICR-C85A-25CD EUDAMED
D-WD-MET-C11A-25FC EUDAMED
D-WO-VD-C41-2565 EUDAMED
Basic UDI-DI
B-WI-MICR-C43A-25A3 EUDAMED
B-WI-MPXV-C42-25L6 EUDAMED
B-WW-SP-C91-25LK EUDAMED
B-06976477340137 EUDAMED
B-WI-MICR-C810C-01TP EUDAMED
B-WI-MICR-C86A-25CQ EUDAMED
B-WI-GON-C71-25FZ EUDAMED
B-WI-FLU-C82-25HN EUDAMED
B-WI-MICR-C83A-25BP EUDAMED
B-WI-MICR-C43A-109N EUDAMED
B-WI-MICR-C85A-25CD EUDAMED
B-WD-MET-C11A-25FC EUDAMED
B-WO-VD-C41-2565 EUDAMED
EMDN Code
W0105099007 DENGUE - RT & POC EUDAMED
W0105099099 VIROLOGY - RT & POC - OTHER EUDAMED
W0102160399 FERTILITY/PREGNANCY RT & POC - OTHER EUDAMED
W0105090199 BACTERIOLOGY - RT & POC - OTHER EUDAMED
W0105099004 INFLUENZA A AND /OR B - RT & POC EUDAMED
W0102160502 AMPHETAMINE/METHAMPHETAMINE SPECIFIC (+ECSTASY) - RT & POC EUDAMED
W0102060309 25-HYDROXYVITAMIN D EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Spain EUDAMED
Bulgaria EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

Yes

EUDAMEDEUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

Yes

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

Bio·Firm by Zhejiang Wantaifu Biotechnology 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

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Manufacturer

Manufacturer
Zhejiang Wantaifu Biotechnology Co., Ltd
EUDAMED SRN
CN-MF-000037582
Authorised Representative
Medunion S.L. ES-AR-000019366

Sources (13)

  • EUDAMED 4645a0ef-232a-45ce-a90b-40ad952cb33c 61 fields · synced Aug 2, 2026
  • EUDAMED 0cd0130b-fce1-44d0-a05b-0734d8ae9767 61 fields · synced May 11, 2026
  • EUDAMED efc871b0-96b3-4b4a-ad8e-18fa394cb471 61 fields · synced May 16, 2026
  • EUDAMED 05af2dbe-10a0-48a4-aeec-120bc126a39b 61 fields · synced May 16, 2026
  • EUDAMED a1aefb3e-3b4d-4acb-bcf0-9380d8106c2e 61 fields · synced May 16, 2026
  • EUDAMED dc86b44a-ded0-4f05-b512-dea7cf555326 61 fields · synced May 17, 2026
  • EUDAMED 1d9634ba-200b-4dd0-944b-66fe45fcafaf 61 fields · synced May 17, 2026
  • EUDAMED c912ab6e-af9f-42ad-bd6a-d9263ed27c30 61 fields · synced May 17, 2026
  • EUDAMED cf965ad9-5e54-4c21-8591-98161acd99c9 61 fields · synced May 17, 2026
  • EUDAMED 5e8c44d2-ef04-4214-814c-0bf221836a78 61 fields · synced May 18, 2026
  • EUDAMED bda9dff0-0022-4e7b-885d-0c1feb6e723c 61 fields · synced May 18, 2026
  • EUDAMED 69715f75-f31a-4a21-995f-2931f5118e99 61 fields · synced May 18, 2026
  • EUDAMED b23edbc8-2e5c-427f-8a67-d3d0ba66d845 61 fields · synced May 19, 2026