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Detection Kit for Chlamydia trachomatis Nucleic Acid (PCR-Fluorescence Probing)

EUDAMED

Class IVD Annex II List B (EU MDR)

Ref DA1141Model Large package, 20 tests/kitRef DA1140Model Large package, 48 tests/kitRef DA1142Model Single tube, 20 tests/kit

by Daan Gene Co., Ltd.

Identity

Device Name
Detection Kit for Chlamydia trachomatis Nucleic Acid (PCR-Fluorescence Probing) EUDAMED
Model / Reference
Large package, 20 tests/kit EUDAMED
DA1141 EUDAMED
Large package, 48 tests/kit EUDAMED
DA1140 EUDAMED
Single tube, 20 tests/kit EUDAMED
DA1142 EUDAMED

Identifiers

Primary DI / UDI-DI
06928103011416 EUDAMED
06928103011409 EUDAMED
06928103011423 EUDAMED
Basic UDI-DI
B-06928103011416 EUDAMED
B-06928103011409 EUDAMED
B-06928103011423 EUDAMED
EMDN Code
W0105010117 CHLAMYDIA TRACHOMATIS DETECTION BY NA REAGENTS EUDAMED

Classification

Device Class
Class IVD Annex II List B EUDAMED
Market of Registration
Sweden 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

Detection Kit for Chlamydia trachomatis Nucleic Acid (PCR-Fluorescence Probing) by Daan Gene Co., Ltd. — Class IVD Annex II List B — IVDD — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
Daan Gene Co., Ltd.
EUDAMED SRN
CN-MF-000025799
Authorised Representative
MDSS GmbH DE-AR-000005430

Sources (3)

  • EUDAMED 6524cf30-14ad-4105-a1ba-a234f1fa75cf 61 fields · synced Jul 20, 2026
  • EUDAMED ec245d0c-c29b-471c-86ab-d964e61e4e65 61 fields · synced May 18, 2026
  • EUDAMED ed97fb10-eed2-47da-9e10-10e0f64bb1fa 61 fields · synced May 19, 2026