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EUDAMED Device Search

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

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D-697180825KFP011GXWL

MDS chromosome and gene anomaly probe detection kit

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000033113
UDI-DI: D-697180825KFP011GXWL
Basic UDI-DI: B-697180825KFP011GXWL
Reference: FP-011-1
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Czechia
Authorised representative: Kingsmead Service B.V.
Last updated: 07.08.2026 11:58

Manufacturer products Authorised representative products Authorised representative actors View details

D-06971808258396WB

ABL1/ABL2/PDGFRB/CRLF2/JAK2 gene break apart probe reagent

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000033113
UDI-DI: D-06971808258396WB
Basic UDI-DI: B-06971808258396WB
Reference: FP-230-2
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Czechia
Authorised representative: Kingsmead Service B.V.
Last updated: 07.08.2026 08:15

Manufacturer products Authorised representative products Authorised representative actors View details

D-06971808258389WE

EVI gene break apart probe reagent

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000033113
UDI-DI: D-06971808258389WE
Basic UDI-DI: B-06971808258389WE
Reference: FP-179-2
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Czechia
Authorised representative: Kingsmead Service B.V.
Last updated: 07.08.2026 08:15

Manufacturer products Authorised representative products Authorised representative actors View details

D-06971808258150V9

ABL1/ABL2/PDGFRB/CRLF2/JAK2 gene break apart probe reagent

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000033113
UDI-DI: D-06971808258150V9
Basic UDI-DI: B-06971808258150V9
Reference: FP-230-4
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Czechia
Authorised representative: Kingsmead Service B.V.
Last updated: 07.08.2026 08:15

Manufacturer products Authorised representative products Authorised representative actors View details

D-06971808257337VL

ABL1/ABL2/PDGFRB/CRLF2/JAK2 gene break apart probe reagent

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000033113
UDI-DI: D-06971808257337VL
Basic UDI-DI: B-06971808257337VL
Reference: FP-230-1
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Czechia
Authorised representative: Kingsmead Service B.V.
Last updated: 07.08.2026 08:15

Manufacturer products Authorised representative products Authorised representative actors View details

D-06971808257283VN

1q21 and 1p32 anomaly probe reagent

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000033113
UDI-DI: D-06971808257283VN
Basic UDI-DI: B-06971808257283VN
Reference: FP-197
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Czechia
Authorised representative: Kingsmead Service B.V.
Last updated: 07.08.2026 08:15

Manufacturer products Authorised representative products Authorised representative actors View details

D-06971808257276VR

E2A gene break apart probe reagent

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000033113
UDI-DI: D-06971808257276VR
Basic UDI-DI: B-06971808257276VR
Reference: FP-183
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Czechia
Authorised representative: Kingsmead Service B.V.
Last updated: 07.08.2026 08:15

Manufacturer products Authorised representative products Authorised representative actors View details

D-06971808257269VU

ETV6 gene break apart probe reagent

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000033113
UDI-DI: D-06971808257269VU
Basic UDI-DI: B-06971808257269VU
Reference: FP-181
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Czechia
Authorised representative: Kingsmead Service B.V.
Last updated: 07.08.2026 08:15

Manufacturer products Authorised representative products Authorised representative actors View details

Universal Sequencing Reaction Kit G400 SM FCS PE150

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Wuhan MGI Tech Co., Ltd.
Manufacturer SRN: CN-MF-000018732
UDI-DI: 06974318130190
Basic UDI-DI: 697431813S-KitMW
Reference: 1000022485
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

D-06971808258365VY

Chromosome 8 centromere probe reagent

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000033113
UDI-DI: D-06971808258365VY
Basic UDI-DI: B-06971808258365VY
Reference: FP-018-2
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Czechia
Authorised representative: Kingsmead Service B.V.
Last updated: 07.08.2026 02:58

Manufacturer products Authorised representative products Authorised representative actors View details

D-06971808258358W3

CLL chromosome and gene anomaly probe detection kit

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000033113
UDI-DI: D-06971808258358W3
Basic UDI-DI: B-06971808258358W3
Reference: FP-014-3
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Czechia
Authorised representative: Kingsmead Service B.V.
Last updated: 07.08.2026 02:58

Manufacturer products Authorised representative products Authorised representative actors View details

D-06971808257252VB

EVI gene break apart probe reagent

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000033113
UDI-DI: D-06971808257252VB
Basic UDI-DI: B-06971808257252VB
Reference: FP-179-1
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Czechia
Authorised representative: Kingsmead Service B.V.
Last updated: 07.08.2026 02:58

Manufacturer products Authorised representative products Authorised representative actors View details

D-06971808257191VG

CDK4 (12q13)/SE12 probe reagent

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000033113
UDI-DI: D-06971808257191VG
Basic UDI-DI: B-06971808257191VG
Reference: FP-149
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Czechia
Authorised representative: Kingsmead Service B.V.
Last updated: 07.08.2026 02:58

Manufacturer products Authorised representative products Authorised representative actors View details

D-06971808257184VK

COL1A1/PDGFB gene fusion t(17;22) probe reagent

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000033113
UDI-DI: D-06971808257184VK
Basic UDI-DI: B-06971808257184VK
Reference: FP-137
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Czechia
Authorised representative: Kingsmead Service B.V.
Last updated: 07.08.2026 02:58

Manufacturer products Authorised representative products Authorised representative actors View details

D-06971808257139VE

3p probe reagent

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000033113
UDI-DI: D-06971808257139VE
Basic UDI-DI: B-06971808257139VE
Reference: FP-105
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Czechia
Authorised representative: Kingsmead Service B.V.
Last updated: 07.08.2026 02:58

Manufacturer products Authorised representative products Authorised representative actors View details

D-06971808257023US

SS18 (SYT) gene break apart probe reagent

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000033113
UDI-DI: D-06971808257023US
Basic UDI-DI: B-06971808257023US
Reference: FP-055
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Czechia
Authorised representative: Kingsmead Service B.V.
Last updated: 07.08.2026 02:58

Manufacturer products Authorised representative products Authorised representative actors View details

D-06971808256965WG

EWSR1 gene break apart probe reagent

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000033113
UDI-DI: D-06971808256965WG
Basic UDI-DI: B-06971808256965WG
Reference: FP-051
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Czechia
Authorised representative: Kingsmead Service B.V.
Last updated: 07.08.2026 02:58

Manufacturer products Authorised representative products Authorised representative actors View details

D-06971808257061V2

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000033113
UDI-DI: D-06971808257061V2
Basic UDI-DI: B-06971808257061V2
Reference: FP-062
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Czechia
Authorised representative: Kingsmead Service B.V.
Last updated: 06.08.2026 23:37

Manufacturer products Authorised representative products Authorised representative actors View details

D-06971808257054V5

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000033113
UDI-DI: D-06971808257054V5
Basic UDI-DI: B-06971808257054V5
Reference: FP-059
EMDN: W01060204
EMDN description: RET
First on market country: Czechia
Authorised representative: Kingsmead Service B.V.
Last updated: 06.08.2026 23:37

Manufacturer products Authorised representative products Authorised representative actors View details

D-06971808256958WK

MYCN gene amplification probe reagent

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000033113
UDI-DI: D-06971808256958WK
Basic UDI-DI: B-06971808256958WK
Reference: FP-048
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Czechia
Authorised representative: Kingsmead Service B.V.
Last updated: 06.08.2026 23:36

Manufacturer products Authorised representative products Authorised representative actors View details