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Harnwegsentzündung

EUDAMED

Class IVD devices for self-testing (EU MDR)

Ref 600101

by Hangzhou Alltest Biotech.Co., Ltd.

Identity

Device Name
Harnwegsentzündung EUDAMED
Model / Reference
600101 EUDAMED

Identifiers

Primary DI / UDI-DI
D-600101MC EUDAMED
Basic UDI-DI
B-600101MC EUDAMED
EMDN Code
W0101060204 URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL) 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

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

No

EUDAMED

Self Testing

Yes

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

No

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

Harnwegsentzündung by Hangzhou Alltest 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

EUDAMED SRN
CN-MF-000010710
Authorised Representative
MedNet EC-REP GmbH DE-AR-000000002

Sources (1)

  • EUDAMED 3eb6156c-2abe-41ac-9444-6b42db5f39e5 61 fields · synced Jun 19, 2026