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Detection Kit for Neisseria gonorrhoeae DNA (PCR-Fluorescence Probing)

EUDAMED

Class IVD General (EU MDR)

Ref DA1191Model Large package, 20 tests/kitRef DA1192Model Single tube, 20 tests/kitRef DA1190Model Large package, 48 tests/kit

by Daan Gene Co., Ltd.

Identity

Device Name
Detection Kit for Neisseria gonorrhoeae DNA (PCR-Fluorescence Probing) EUDAMED
Model / Reference
Large package, 20 tests/kit EUDAMED
DA1191 EUDAMED
Single tube, 20 tests/kit EUDAMED
DA1192 EUDAMED
Large package, 48 tests/kit EUDAMED
DA1190 EUDAMED

Identifiers

Primary DI / UDI-DI
06928103011911 EUDAMED
06928103011928 EUDAMED
06928103011904 EUDAMED
Basic UDI-DI
B-06928103011911 EUDAMED
B-06928103011928 EUDAMED
B-06928103011904 EUDAMED
EMDN Code
W0105010203 GONOCOCCAL DETECTION BY NA REAGENTS EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
France 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

Detection Kit for Neisseria gonorrhoeae DNA (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
Lotus NL B.V. NL-AR-000000121

Sources (3)

  • EUDAMED 44b452e6-107f-4e68-943e-5ffde6273386 61 fields · synced Jul 15, 2026
  • EUDAMED 56dd70f6-0caf-448c-b187-63848a1b8c2d 61 fields · synced May 17, 2026
  • EUDAMED d24d720a-0bf2-4eaa-b298-5f8d62d62b0a 61 fields · synced May 18, 2026