Pregabalin(PGB)Rapid Test(Urine)

EUDAMED

Class IVD General (EU MDR)

Ref PGB-1011/PGB-1012/PGB-1014

by Safecare Biotech (hangzhou) Co., Ltd.

Identity

Trade Name: Pregabalin(PGB)Rapid Test(Urine) EUDAMED
Device Name: Pregabalin(PGB)Rapid Test(Urine) EUDAMED
Model / Reference: PGB-1011/PGB-1012/PGB-1014 EUDAMED

Identifiers

Primary DI / UDI-DI: D-697424646PGB000HNV3 EUDAMED
Basic UDI-DI: B-697424646PGB000HNV3 EUDAMED
EMDN Code: W0102160599 DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER EUDAMED

Classification

Device Class: Class IVD General EUDAMED
Market of Registration: Germany EUDAMED

Clinical & Handling

Sterile

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

Pregabalin(PGB)Rapid Test(Urine) by Safecare Biotech (Hangzhou) 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-697424646PGB000HNV3	Class IVD General	Active

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Manufacturer

Manufacturer: Safecare Biotech (hangzhou) Co., Ltd.
EUDAMED SRN: CN-MF-000019109
Authorised Representative: Medunion S.L. ES-AR-000019366

Sources (1)

EUDAMED 4bafccff-284a-4568-99a9-6aa1e76c4747 61 fields · synced Jul 25, 2026