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Diagnostic Kit for Mycoplasma pneumoniae DNA (PCR-Fluorescence Probing)

EUDAMED

Class IVD General (EU MDR)

Ref DA1111Model Large package, 48 tests/kitRef DA1112Model Single tube, 20 tests/kitRef DA1110Model Large package, 20 tests/kit

by Daan Gene Co., Ltd.

Identity

Device Name
Diagnostic Kit for Mycoplasma pneumoniae DNA (PCR-Fluorescence Probing) EUDAMED
Model / Reference
Large package, 48 tests/kit EUDAMED
DA1111 EUDAMED
Single tube, 20 tests/kit EUDAMED
DA1112 EUDAMED
Large package, 20 tests/kit EUDAMED
DA1110 EUDAMED

Identifiers

Primary DI / UDI-DI
06928103011119 EUDAMED
06928103011126 EUDAMED
06928103011102 EUDAMED
Basic UDI-DI
B-06928103011119 EUDAMED
B-06928103011126 EUDAMED
B-06928103011102 EUDAMED
EMDN Code
W0105010803 MYCOPLASMA / UREAPLASMA 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

Diagnostic Kit for Mycoplasma pneumoniae 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 5d213714-3e30-4b39-ba56-b00f1b3f95c4 61 fields · synced Jul 15, 2026
  • EUDAMED a2998633-3638-451b-9e46-9dcb549d05b9 61 fields · synced May 17, 2026
  • EUDAMED 2dabb4ba-18f7-4eb4-ab0c-1e4d14626a5d 61 fields · synced May 18, 2026