Carisoprodol(SOMA) Rapid Test(Saliva)

EUDAMED

Class IVD General (EU MDR)

Ref SOMA-7011/SOMA-7012/SOMA-7014/SOMA-7015

by Safecare Biotech (hangzhou) Co., Ltd.

Identity

Trade Name: Carisoprodol(SOMA) Rapid Test(Saliva) EUDAMED
Device Name: Carisoprodol(SOMA) Rapid Test(Saliva) EUDAMED
Model / Reference: SOMA-7011/SOMA-7012/SOMA-7014/SOMA-7015 EUDAMED

Identifiers

Primary DI / UDI-DI: D-697424646SOMA002YQRR EUDAMED
Basic UDI-DI: B-697424646SOMA002YQRR 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

Carisoprodol(SOMA) Rapid Test(Saliva) 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-697424646SOMA002YQRR	Class IVD General	Active

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Manufacturer

Manufacturer: Safecare Biotech (hangzhou) Co., Ltd.
EUDAMED SRN: CN-MF-000019109
Authorised Representative: UnicareQ GmbH DE-AR-000051497

Sources (1)

EUDAMED fd4fa0e2-d026-4ec2-be1b-3bc921d2639d 61 fields · synced Oct 6, 2026