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Nucleic Acid Extraction Kit

EUDAMED

Class A (EU MDR)

Ref DA1000Ref DA0600Ref DA0604Ref DA0602

by Daan Gene Co., Ltd.

Identity

Device Name
Nucleic Acid Extraction Kit EUDAMED
Model / Reference
DA1000 EUDAMED
DA0600 EUDAMED
DA0604 EUDAMED
DA0602 EUDAMED

Identifiers

Primary DI / UDI-DI
06928103010006 EUDAMED
06928103006009 EUDAMED
06928103006047 EUDAMED
06928103006023 EUDAMED
Basic UDI-DI
69281030100XE2 EUDAMED
69281030060XER EUDAMED
EMDN Code
W0599 IVD GENERAL USE CONSUMABLE DEVICES - OTHER EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
Denmark EUDAMED
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

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

New Device

No

EUDAMED

Nucleic Acid Extraction Kit by Daan Gene Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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Manufacturer

Manufacturer
Daan Gene Co., Ltd.
EUDAMED SRN
CN-MF-000025799
Authorised Representative
Lotus NL B.V. NL-AR-000000121

Sources (4)

  • EUDAMED c83b6405-a51a-4f64-a475-76926a7797a9 61 fields · synced Aug 3, 2026
  • EUDAMED fb3be0bd-9995-46ea-9829-c897bfab4a2a 61 fields · synced May 16, 2026
  • EUDAMED 4c4a4c11-14a0-4b97-a03e-a9c81ef70828 61 fields · synced May 18, 2026
  • EUDAMED 7325987c-42bb-4010-bd4b-24d189789418 61 fields · synced May 18, 2026