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Detection kit for Ureaplasma Urealyticum Nucleic Acid (PCR-Fluorescence Probing)

EUDAMED

Class IVD General (EU MDR)

Ref DA1122Model Single tube, 20 tests/kitRef DA1121Model Large package, 20 tests/kitRef DA1120Model Large package, 48 tests/kit

by Daan Gene Co., Ltd.

Identity

Device Name
Detection kit for Ureaplasma Urealyticum Nucleic Acid (PCR-Fluorescence Probing) EUDAMED
Model / Reference
Single tube, 20 tests/kit EUDAMED
DA1122 EUDAMED
Large package, 20 tests/kit EUDAMED
DA1121 EUDAMED
Large package, 48 tests/kit EUDAMED
DA1120 EUDAMED

Identifiers

Primary DI / UDI-DI
06928103011225 EUDAMED
06928103011218 EUDAMED
06928103011201 EUDAMED
Basic UDI-DI
B-06928103011225 EUDAMED
B-06928103011218 EUDAMED
B-06928103011201 EUDAMED
EMDN Code
W0105010803 MYCOPLASMA / UREAPLASMA DETECTION BY NA REAGENTS EUDAMED

Classification

Device Class
Class IVD General 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 Ureaplasma Urealyticum Nucleic Acid (PCR-Fluorescence Probing) by Daan Gene Co., Ltd. — Class IVD General — 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 7f531edb-81b6-4a54-9cc3-905ab0a98dbf 61 fields · synced Jul 20, 2026
  • EUDAMED 1b40dc27-e9be-4981-8c5e-9690bb69af7d 61 fields · synced May 17, 2026
  • EUDAMED f54c5e49-d22d-4ffa-9dbe-77939e6c9cd0 61 fields · synced May 17, 2026