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One Step HCG Urine Test

EUDAMED

Class IVD devices for self-testing (EU MDR)

Ref W1-M (20mIU)Ref W1-CRef W1-M (10mIU)Ref W1-C (20mIU)Ref W1-S (10mIU)

by Guangzhou Wondfo Biotech Co., Ltd.

Identity

Device Name
One Step HCG Urine Test EUDAMED
Model / Reference
W1-M (20mIU) EUDAMED
W1-C EUDAMED
W1-M (10mIU) EUDAMED
W1-C (20mIU) EUDAMED
W1-S (10mIU) EUDAMED

Identifiers

Primary DI / UDI-DI
D-W1-M-20mIUKJ EUDAMED
D-W1-CJ9 EUDAMED
D-W1-M-10mIUK7 EUDAMED
D-W1-C-20mIUE8 EUDAMED
D-W1-S-10mIUND EUDAMED
Basic UDI-DI
B-W1-M-20mIUKJ EUDAMED
B-W1-CJ9 EUDAMED
B-W1-M-10mIUK7 EUDAMED
B-W1-C-20mIUE8 EUDAMED
B-W1-S-10mIUND EUDAMED
EMDN Code
W0102160302 HCG - RT & POC EUDAMED

Classification

Device Class
Class IVD devices for self-testing EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

Yes

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

No

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

One Step HCG Urine Test by Guangzhou Wondfo Biotech Co., Ltd. — Class IVD devices for self-testing — 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
Guangzhou Wondfo Biotech Co., Ltd.
EUDAMED SRN
CN-MF-000000689
Authorised Representative
QbD RepS BV BE-AR-000000040

Sources (5)

  • EUDAMED a4a49f4d-8c0e-4225-97fd-7a9da922cf07 61 fields · synced Aug 3, 2026
  • EUDAMED aaf68362-601d-400d-b236-963cfedf16ac 61 fields · synced May 17, 2026
  • EUDAMED bcaa7f01-3555-4fc7-95d8-442901282a14 61 fields · synced Jul 9, 2026
  • EUDAMED 68de980a-1356-48d7-a08f-628c25112b71 61 fields · synced Jul 20, 2026
  • EUDAMED 6c424a36-bb0e-45f7-b468-057ad665cd9b 61 fields · synced Aug 3, 2026