Dynamiker Fungus (1-3)-β-D-Glucan Assay (POCT Chemiluminescence)

EUDAMED

Class IVD General (EU MDR)

Ref DNK-1901-63Model 48 testsModel 48 tests/kit Model 24 tests/kit

by Dynamiker Biotechnology (Tianjin) Co., Ltd.

Identity

Device Name: Dynamiker Fungus (1-3)-β-D-Glucan Assay (POCT Chemiluminescence) EUDAMED
Model / Reference: 48 tests EUDAMED
DNK-1901-63 EUDAMED
48 tests/kit EUDAMED
24 tests/kit EUDAMED

Identifiers

Primary DI / UDI-DI: 06930317855410 EUDAMED
06930317866553 EUDAMED
06930317830684 EUDAMED
Basic UDI-DI: B-06930317855410 EUDAMED
B-06930317866553 EUDAMED
B-06930317830684 EUDAMED
EMDN Code: W0105060399 MYCOLOGY IMMUNOASSAYS - OTHER EUDAMED
W01029099 IMMUNOCHEMISTRY REAGENTS - OTHER EUDAMED

Classification

Device Class: Class IVD General EUDAMED
Market of Registration: Türkiye EUDAMED
Netherlands EUDAMED

Clinical & Handling

Sterile

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMEDEUDAMED

Microbial Substances

EUDAMEDEUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

Dynamiker Fungus (1-3)-β-D-Glucan Assay (POCT Chemiluminescence) by Dynamiker Biotechnology (Tianjin) Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED

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-06930317855410	Class IVD General	Active

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Manufacturer

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
EUDAMED SRN: CN-MF-000001133
Authorised Representative: Lotus NL B.V. NL-AR-000000121

Sources (3)

EUDAMED ca6161c4-9f7a-4ff2-b002-29c5af1057f7 61 fields · synced Oct 6, 2026
EUDAMED cb8615fa-11ef-4a14-a72e-d0b3e0c0e312 61 fields · synced May 18, 2026
EUDAMED f0d02859-9324-4305-923f-7f048afdb558 61 fields · synced May 19, 2026