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CTX-M β-lactamases Rapid Test

EUDAMED

Class IVD General (EU MDR)

Ref P261104

by Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.

Identity

Trade Name
CTX-M β-lactamases Rapid Test EUDAMED
Device Name
CTX-M β-lactamases Rapid Test EUDAMED
Model / Reference
P261104 EUDAMED

Identifiers

Primary DI / UDI-DI
16972698601221 EUDAMED
Basic UDI-DI
B-16972698601221 EUDAMED
EMDN Code
W0104080505 TARGETED RESISTANCE TESTS - ESBL EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Spain EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

Yes

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

CTX-M β-lactamases Rapid Test by Hangzhou Genesis Biodetection and Biocontrol Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
EUDAMED SRN
CN-MF-000013495
Authorised Representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Sources (1)

  • EUDAMED 68390681-09e3-4dc0-8140-952b1a4e2ca9 61 fields · synced Jul 17, 2026