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Diagnostic Kit for Calprotectin（Fluorescence Immunochromatographic Assay）

EUDAMED

Class IVD General (EU MDR)

Ref A1C205020001, A1C205020002, A1C205020003, A1C205020004, A1C205020005, A1C205020006, A1C205020007.Model 1 test/kit, 2 tests/kit, 5 tests/kit, 10 tests/kit, 25 tests/kit, 50 tests/kit, 100 tests/kit.

by Xiamen Wiz Biotech Co., Ltd.

Identity

Device Name
Diagnostic Kit for Calprotectin（Fluorescence  Immunochromatographic Assay） EUDAMED
Model / Reference
1 test/kit, 2 tests/kit, 5 tests/kit, 10 tests/kit, 25 tests/kit, 50 tests/kit, 100 tests/kit. EUDAMED
A1C205020001, A1C205020002, A1C205020003, A1C205020004, A1C205020005, A1C205020006, A1C205020007. EUDAMED

Identifiers

Primary DI / UDI-DI
06971100211365 EUDAMED
Basic UDI-DI
B-06971100211365 EUDAMED
EMDN Code
W01021699 RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

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

Diagnostic Kit for Calprotectin（Fluorescence Immunochromatographic Assay） by Xiamen Wiz Biotech 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
Xiamen Wiz Biotech Co., Ltd.
EUDAMED SRN
CN-MF-000029590
Authorised Representative
Lotus NL B.V. NL-AR-000000121

Sources (2)

  • EUDAMED be334af1-90a4-4600-982a-c9b503ce829e 61 fields · synced Oct 6, 2026
  • EUDAMED be334af1-90a4-4600-982a-c9b503ce829e-1 61 fields · synced Jun 10, 2026