Public EUDAMED Search

EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

Last updated

21.09.2026 18:16

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Successful

Device

3152549

Actor

47649

Certificate

3295

Active filter:Manufacturer SRN:CN-MF-000007252

18 device results listed.

Page 1 / 1

GENEDIAN

Cell Preservation Solution

IVD Class AIVDR 2017/746Not intended for EU marketKitProfessional testingReagentSingle use
Manufacturer
Hangzhou DIAN Biotechnology Co., Ltd.
Manufacturer SRN
CN-MF-000007252
UDI-DI
06934244550004
Basic UDI-DI
69342445RA001JL
Reference
P131-02025
EMDN
W05019099
EMDN description
SAMPLES COLLECTION DEVICES - OTHER
First on market country
-
Authorised representative
Lotus NL B.V.
Last updated
31.07.2026 18:56
GENEDIAN

Virus Collection and Preservation System

IVD Class AIVDR 2017/746Not intended for EU marketKitProfessional testingReagentSingle use
Manufacturer
Hangzhou DIAN Biotechnology Co., Ltd.
Manufacturer SRN
CN-MF-000007252
UDI-DI
06934244540043
Basic UDI-DI
69342445RA002JN
Reference
P131-04050
EMDN
W05019099
EMDN description
SAMPLES COLLECTION DEVICES - OTHER
First on market country
-
Authorised representative
Lotus NL B.V.
Last updated
31.07.2026 18:56
GENEDIAN

Nucleic Acid Extraction and Purification Kit

IVD Class AIVDR 2017/746Not intended for EU marketKitProfessional testingReagentSingle use
Manufacturer
Hangzhou DIAN Biotechnology Co., Ltd.
Manufacturer SRN
CN-MF-000007252
UDI-DI
06934244530051
Basic UDI-DI
69342445RA004JS
Reference
P121-51048
EMDN
W02069085
EMDN description
VARIOUS SAMPLE PROCESSING INSTRUMENTS - CONSUMABLES
First on market country
-
Authorised representative
Lotus NL B.V.
Last updated
31.07.2026 18:56
GENEDIAN

Nucleic Acid Extraction and Purification Kit (HPV)

IVD Class AIVDR 2017/746Not intended for EU marketKitProfessional testingReagentSingle use
Manufacturer
Hangzhou DIAN Biotechnology Co., Ltd.
Manufacturer SRN
CN-MF-000007252
UDI-DI
06934244530044
Basic UDI-DI
69342445RA003JQ
Reference
P121-52048
EMDN
W02069085
EMDN description
VARIOUS SAMPLE PROCESSING INSTRUMENTS - CONSUMABLES
First on market country
-
Authorised representative
Lotus NL B.V.
Last updated
31.07.2026 18:56
GENEDIAN

EB-1000

IVD Class AIVDR 2017/746Not intended for EU marketInstrumentProfessional testing
Manufacturer
Hangzhou DIAN Biotechnology Co., Ltd.
Manufacturer SRN
CN-MF-000007252
UDI-DI
06934244500153
Basic UDI-DI
69342445IA004FP
Reference
P111-00032
EMDN
W02069099
EMDN description
VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country
-
Authorised representative
Lotus NL B.V.
Last updated
31.07.2026 18:56
GENEDIAN

EB-1100

IVD Class AIVDR 2017/746Not intended for EU marketInstrumentProfessional testing
Manufacturer
Hangzhou DIAN Biotechnology Co., Ltd.
Manufacturer SRN
CN-MF-000007252
UDI-DI
06934244500146
Basic UDI-DI
69342445IA003FM
Reference
P111-01032
EMDN
W02069099
EMDN description
VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country
-
Authorised representative
Lotus NL B.V.
Last updated
31.07.2026 18:56
GENEDIAN

iRapid 4

IVD Class AIVDR 2017/746Not intended for EU marketInstrumentProfessional testing
Manufacturer
Hangzhou DIAN Biotechnology Co., Ltd.
Manufacturer SRN
CN-MF-000007252
UDI-DI
06934244500139
Basic UDI-DI
69342445IA002FK
Reference
P114-00004
EMDN
W02050301
EMDN description
NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country
-
Authorised representative
Lotus NL B.V.
Last updated
31.07.2026 18:56
GENEDIAN

SARS-CoV-2 and Influenza A/B Nucleic Acid Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
Hangzhou DIAN Biotechnology Co., Ltd.
Manufacturer SRN
CN-MF-000007252
UDI-DI
D-RA012UG
Basic UDI-DI
B-RA012UG
Reference
P122-06048
EMDN
W0105040599
EMDN description
VIROLOGY - NA REAGENTS - OTHER
First on market country
Germany
Authorised representative
Lotus NL B.V.
Last updated
15.07.2026 05:25
GENEDIAN

Human Papillomavirus Nucleic Acid Detection Kit (Fluorescence PCR Method)

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
Hangzhou DIAN Biotechnology Co., Ltd.
Manufacturer SRN
CN-MF-000007252
UDI-DI
D-RA011UE
Basic UDI-DI
B-RA011UE
Reference
P122-02096
EMDN
W0105041003
EMDN description
PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country
Germany
Authorised representative
Lotus NL B.V.
Last updated
15.07.2026 05:25
GENEDIAN

POC SARS-CoV-2 Nucleic Acid Detection Kit

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagent
Manufacturer
Hangzhou DIAN Biotechnology Co., Ltd.
Manufacturer SRN
CN-MF-000007252
UDI-DI
D-RA010UC
Basic UDI-DI
B-RA010UC
Reference
P122-05024
EMDN
W0105099099
EMDN description
VIROLOGY - RT & POC - OTHER
First on market country
Germany
Authorised representative
Lotus NL B.V.
Last updated
15.07.2026 05:25
GENEDIAN

SARS-CoV-2 Neutralization Antibody Detection Kit(ELISA)

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
Hangzhou DIAN Biotechnology Co., Ltd.
Manufacturer SRN
CN-MF-000007252
UDI-DI
D-RA009UT
Basic UDI-DI
B-RA009UT
Reference
I121-01096; I121-01480
EMDN
W0105040619
EMDN description
CORONAVIRUS
First on market country
Germany
Authorised representative
Lotus NL B.V.
Last updated
15.07.2026 05:25
GENEDIAN

SARS-CoV-2 Neutralization Antibody Detection Kit

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagent
Manufacturer
Hangzhou DIAN Biotechnology Co., Ltd.
Manufacturer SRN
CN-MF-000007252
UDI-DI
D-RA008UR
Basic UDI-DI
B-RA008UR
Reference
L121-10120
EMDN
W0105040619
EMDN description
CORONAVIRUS
First on market country
Germany
Authorised representative
Lotus NL B.V.
Last updated
15.07.2026 05:25
GENEDIAN

COVID-19 Antigen Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use
Manufacturer
Hangzhou DIAN Biotechnology Co., Ltd.
Manufacturer SRN
CN-MF-000007252
UDI-DI
D-RA007UP
Basic UDI-DI
B-RA007UP
Reference
L111-10125
EMDN
W0105040619
EMDN description
CORONAVIRUS
First on market country
Germany
Authorised representative
Lotus NL B.V.
Last updated
15.07.2026 05:25
GENEDIAN

Novel Coronavirus (SARS-CoV-2) Nucleic Acid Detection Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
Hangzhou DIAN Biotechnology Co., Ltd.
Manufacturer SRN
CN-MF-000007252
UDI-DI
D-RA006UM
Basic UDI-DI
B-RA006UM
Reference
P122-01048
EMDN
W0105040519
EMDN description
CORONAVIRUS - NA REAGENTS
First on market country
Germany
Authorised representative
Lotus NL B.V.
Last updated
15.07.2026 05:25
GENEDIAN

Human Papillomavirus DNA Test Kit(Fluorescence Melting Curve Method)

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
Hangzhou DIAN Biotechnology Co., Ltd.
Manufacturer SRN
CN-MF-000007252
UDI-DI
D-RA005UK
Basic UDI-DI
B-RA005UK
Reference
P122-08048; P122-08240; P122-08480
EMDN
W0105041004
EMDN description
FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS
First on market country
Germany
Authorised representative
Lotus NL B.V.
Last updated
15.07.2026 05:25