Dynamiker Gram Negative Bacterial Endotoxin Assay(Chromogenic)

EUDAMED

Class IVD General (EU MDR)

Ref DNK-1901-4Model 12 tests（A）Model 12 tests（B）Model 6 tests

by Dynamiker Biotechnology (Tianjin) Co., Ltd.

Identity

Device Name: Dynamiker Gram Negative Bacterial Endotoxin Assay(Chromogenic) EUDAMED
Model / Reference: 12 tests（A） EUDAMED
DNK-1901-4 EUDAMED
12 tests（B） EUDAMED
6 tests EUDAMED

Identifiers

Primary DI / UDI-DI: 06930317811867 EUDAMED
06930317811850 EUDAMED
06930317801097 EUDAMED
Basic UDI-DI: B-06930317811867 EUDAMED
B-06930317811850 EUDAMED
B-06930317801097 EUDAMED
EMDN Code: W01019099 CLINICAL CHEMISTRY REAGENTS - OTHER EUDAMED

Classification

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

Clinical & Handling

Sterile

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

Yes

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

Category: Nucleic acid extraction/isolation kit IVD

Dynamiker Gram Negative Bacterial Endotoxin Assay(Chromogenic) by Dynamiker Biotechnology (Tianjin) Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED

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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-06930317811867	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 4ccb9b0d-c937-4bac-96d4-30c2d94e4035 61 fields · synced Sep 17, 2026
EUDAMED edc975cb-825e-4a96-a2ab-34d63f3dfb51 61 fields · synced May 19, 2026
EUDAMED 80b183c2-3bd3-4de4-b5e4-a9d61d50334b 61 fields · synced May 19, 2026