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Nucleic Acid Isolation or Purification Kit

EUDAMED

Class A (EU MDR)

Ref DA0871Ref DA0870

by Daan Gene Co., Ltd.

Identity

Device Name
Nucleic Acid Isolation or Purification Kit EUDAMED
Model / Reference
DA0871 EUDAMED
DA0870 EUDAMED

Identifiers

Primary DI / UDI-DI
06928103008713 EUDAMED
06928103008706 EUDAMED
Basic UDI-DI
69281030087XFQ EUDAMED
EMDN Code
W0599 IVD GENERAL USE CONSUMABLE DEVICES - OTHER EUDAMED

Classification

Device Class
Class A 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

New Device

No

EUDAMED

Nucleic Acid Isolation or Purification 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 (2)

  • EUDAMED 164f4fa4-b3cf-4c64-89c7-55e5f72dafd1 61 fields · synced Jul 24, 2026
  • EUDAMED 689350d4-95ca-49ff-8f24-1188988270e1 61 fields · synced May 19, 2026