Chagas Rapid Test (WB +2 more)

EUDAMED

Class IVD General (EU MDR)

Ref CHA-4011/CHA-4012

by Safecare Biotech (hangzhou) Co., Ltd.

Identity

Trade Name: Chagas Rapid Test (WB/S/P) EUDAMED
Device Name: Chagas Rapid Test (WB/S/P) EUDAMED
Model / Reference: CHA-4011/CHA-4012 EUDAMED

Identifiers

Primary DI / UDI-DI: D-697424646CHA001CKLY EUDAMED
Basic UDI-DI: B-697424646CHA001CKLY EUDAMED
EMDN Code: W0105090499 PARASITES - RT & POC - OTHER EUDAMED
Models / Variants: WB EUDAMED
S EUDAMED
P 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

Chagas Rapid Test (WB +2 more) by Safecare Biotech (Hangzhou) Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — 3 models — 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-697424646CHA001CKLY	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 67197ea5-0fc1-4651-9ec0-80ff6ef14ec6 61 fields · synced Jun 19, 2026