← Back to catalogue

Detection Kit for Epstein-Barr Virus Nucleic Acid (PCR-Fluorescence Probing)

EUDAMED

Class IVD General (EU MDR)

Ref DA1251Model Large package, 48 tests/kitRef DA1252Model Single tube, 20 tests/kitRef DA1250Model Large package, 20 tests/kit

by Daan Gene Co., Ltd.

Identity

Device Name
Detection Kit for Epstein-Barr Virus Nucleic Acid (PCR-Fluorescence Probing) EUDAMED
Model / Reference
Large package, 48 tests/kit EUDAMED
DA1251 EUDAMED
Single tube, 20 tests/kit EUDAMED
DA1252 EUDAMED
Large package, 20 tests/kit EUDAMED
DA1250 EUDAMED

Identifiers

Primary DI / UDI-DI
06928103012512 EUDAMED
06928103012529 EUDAMED
06928103012505 EUDAMED
Basic UDI-DI
B-06928103012512 EUDAMED
B-06928103012529 EUDAMED
B-06928103012505 EUDAMED
EMDN Code
W0105040403 EBV - NA REAGENTS EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
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 Epstein-Barr Virus 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

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

Sources (3)

  • EUDAMED 98b702de-36e6-421f-ba17-f43a42da1ab2 61 fields · synced Jul 16, 2026
  • EUDAMED d29e2238-6436-476a-922a-e7bf70cf9d7a 61 fields · synced May 18, 2026
  • EUDAMED b6b5a2e1-5c03-4b1b-8613-66d9affa9a5a 61 fields · synced May 18, 2026