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Genedian

EUDAMED

Class IVD General (EU MDR)

Ref P122-06048Ref P131-01050Ref P122-01048Ref P131-04050Ref L111-10125Ref P114-00004Model iRapid 4Ref P121-52048Ref P131-02025

by Hangzhou DIAN Biotechnology Co., Ltd.

Identity

Trade Name
GENEDIAN EUDAMED
Device Name
SARS-CoV-2 and Influenza A/B Nucleic Acid Detection Kit EUDAMED
Cell Preservation Solution EUDAMED
Novel Coronavirus (SARS-CoV-2) Nucleic Acid Detection Kit (PCR-Fluorescence Probing) EUDAMED
Virus Collection and Preservation System EUDAMED
COVID-19 Antigen Test Cassette EUDAMED
iRapid4 POC RT-PCR Detection System EUDAMED
Nucleic Acid Extraction and Purification Kit (HPV) EUDAMED
Model / Reference
P122-06048 EUDAMED
P131-01050 EUDAMED
P122-01048 EUDAMED
P131-04050 EUDAMED
L111-10125 EUDAMED
iRapid 4 EUDAMED
P114-00004 EUDAMED
P121-52048 EUDAMED
P131-02025 EUDAMED

Identifiers

Primary DI / UDI-DI
D-RA012UG EUDAMED
06934244550011 EUDAMED
D-RA006UM EUDAMED
06934244540043 EUDAMED
D-RA007UP EUDAMED
06934244500139 EUDAMED
06934244530044 EUDAMED
06934244550004 EUDAMED
Basic UDI-DI
B-RA012UG EUDAMED
69342445RA001JL EUDAMED
B-RA006UM EUDAMED
69342445RA002JN EUDAMED
B-RA007UP EUDAMED
69342445IA002FK EUDAMED
69342445RA003JQ EUDAMED
EMDN Code
W0105040599 VIROLOGY - NA REAGENTS - OTHER EUDAMED
W05019099 SAMPLES COLLECTION DEVICES - OTHER EUDAMED
W0105040519 EUDAMED
W0105040619,W0105099099 EUDAMED
W02050301 NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS EUDAMED
W02069085 VARIOUS SAMPLE PROCESSING INSTRUMENTS - CONSUMABLES EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Class A EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMEDEUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMEDEUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMEDEUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMEDEUDAMED

New Device

No

EUDAMED

Genedian by Hangzhou DIAN Biotechnology Co., Ltd. — Class IVD General — IVDD, IVDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

European Union Active

CE/IVDR

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Manufacturer

Manufacturer
Hangzhou DIAN Biotechnology Co., Ltd.
EUDAMED SRN
CN-MF-000007252
Authorised Representative
Lotus NL B.V. NL-AR-000000121

Sources (8)

  • EUDAMED b061d767-52a6-4979-996b-32148617b14a 61 fields · synced Oct 6, 2026
  • EUDAMED a2911c4f-afaa-4ce8-83f3-b85ea07c8a01 61 fields · synced May 17, 2026
  • EUDAMED 36cff955-6332-4694-ad4d-300a4f339384 61 fields · synced May 18, 2026
  • EUDAMED 74704336-10df-48a1-9fc4-5f595c3a20a8 61 fields · synced May 18, 2026
  • EUDAMED 189e827d-53aa-48f6-a627-a0014ea5ead4 61 fields · synced May 18, 2026
  • EUDAMED ac8824bc-37cc-4e33-b05e-3df9a0e63407 61 fields · synced May 18, 2026
  • EUDAMED cb94d15d-7f49-4920-b3e1-7637222c5f3d 61 fields · synced May 19, 2026
  • EUDAMED 3fec88fe-0891-4f4d-b7d9-82e0f0025a02 61 fields · synced May 19, 2026