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EUDAMED Device Search

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Last updated

23.09.2026 04:15

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Device

3540602

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Certificate

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Active filter:EMDN:W0106

1000+ device results listed.

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D-06971808258204V7

FGFR1/PDGFRA/PDGFRB 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-06971808258204V7
Basic UDI-DI
B-06971808258204V7
Reference
FP-232-3
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
08.08.2026 02:18
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-06971808257641VS

NTRK1/NTRK2/NTRK3 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-06971808257641VS
Basic UDI-DI
B-06971808257641VS
Reference
FP-231-3
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
08.08.2026 02:18
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-06971808258198W5

-

IVD generalNot specifiedOn the marketSingle use
Manufacturer
Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN
CN-MF-000033113
UDI-DI
D-06971808258198W5
Basic UDI-DI
B-06971808258198W5
Reference
FP-233-1
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 23:41
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-06971808258143VC

-

IVD generalNot specifiedOn the marketSingle use
Manufacturer
Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN
CN-MF-000033113
UDI-DI
D-06971808258143VC
Basic UDI-DI
B-06971808258143VC
Reference
FP-233-4
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 23:41
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-06971808258136VF

-

IVD generalNot specifiedOn the marketSingle use
Manufacturer
Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN
CN-MF-000033113
UDI-DI
D-06971808258136VF
Basic UDI-DI
B-06971808258136VF
Reference
FP-233-2
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 23:31
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-06971808257658WB

-

IVD generalNot specifiedOn the marketSingle use
Manufacturer
Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN
CN-MF-000033113
UDI-DI
D-06971808257658WB
Basic UDI-DI
B-06971808257658WB
Reference
FP-231-1
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 23:31
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-06971808257504VF

Prenatal chromosomes probe detection kit

IVD generalIVDDOn the marketProfessional testingReagentSingle use
Manufacturer
Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN
CN-MF-000033113
UDI-DI
D-06971808257504VF
Basic UDI-DI
B-06971808257504VF
Reference
FP-314
EMDN
W0106010301
EMDN description
DOWN'S SYNDROME
First on market country
Czechia
Authorised representative
Kingsmead Service B.V.
Last updated
07.08.2026 23:31
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-06971808257498WD

13q probe reagent

IVD generalIVDDOn the marketProfessional testingReagentSingle use
Manufacturer
Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN
CN-MF-000033113
UDI-DI
D-06971808257498WD
Basic UDI-DI
B-06971808257498WD
Reference
FP-305-1
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 23:31
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-06971808257436VP

-

IVD generalNot specifiedOn the marketSingle use
Manufacturer
Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN
CN-MF-000033113
UDI-DI
D-06971808257436VP
Basic UDI-DI
B-06971808257436VP
Reference
FP-245-3
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 23:30
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-06971808257412V9

BCL6/MYC/IGH/[BCL2/IGH] gene probe reagent

IVD generalIVDDOn the marketProfessional testingReagentSingle use
Manufacturer
Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN
CN-MF-000033113
UDI-DI
D-06971808257412V9
Basic UDI-DI
B-06971808257412V9
Reference
FP-242-3
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 23:30
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-06971808257399WA

[MAFB/IGH]/[CCND3/IGH]/[MYC/IGH] gene fusion probe reagent

IVD generalIVDDOn the marketProfessional testingReagentSingle use
Manufacturer
Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN
CN-MF-000033113
UDI-DI
D-06971808257399WA
Basic UDI-DI
B-06971808257399WA
Reference
FP-234-2
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 23:30
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-06971808257382VR

[IGH/CCND1]/[IGH/MAF]/[IGH/MAFB]/[IGH/FGFR3] gene fusion probe reagent

IVD generalIVDDOn the marketProfessional testingReagentSingle use
Manufacturer
Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN
CN-MF-000033113
UDI-DI
D-06971808257382VR
Basic UDI-DI
B-06971808257382VR
Reference
FP-233-3
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 23:30
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-06971808257375VU

FGFR1/PDGFRA/PDGFRB 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-06971808257375VU
Basic UDI-DI
B-06971808257375VU
Reference
FP-232-1
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 23:30
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-06971808257368VX

NTRK1/NTRK2/NTRK3 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-06971808257368VX
Basic UDI-DI
B-06971808257368VX
Reference
FP-231-2
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 23:30
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
SALSA MLPA Probemix P095 Aneuploidy

A4

IVD Class CIVDR 2017/746On the marketProfessional testingReagent
Manufacturer
MRC Holland B.V.
Manufacturer SRN
NL-MF-000000437
UDI-DI
08720211481307
Basic UDI-DI
872021148P09569
Reference
P095-025R
EMDN
W0106010399
EMDN description
CHROMOSOMAL DISORDERS TESTS - OTHER
First on market country
Netherlands
Authorised representative
-
Last updated
07.08.2026 23:11
Manufacturer productsView details
SALSA MLPA Probemix P095 Aneuploidy

-

IVD Class CIVDR 2017/746On the marketProfessional testingReagent
Manufacturer
MRC Holland B.V.
Manufacturer SRN
NL-MF-000000437
UDI-DI
08720211481314
Basic UDI-DI
872021148P09569
Reference
P095-050R
EMDN
W0106010399
EMDN description
CHROMOSOMAL DISORDERS TESTS - OTHER
First on market country
-
Authorised representative
-
Last updated
07.08.2026 22:47
Manufacturer productsView details
SALSA MLPA Probemix P095 Aneuploidy

-

IVD Class CIVDR 2017/746On the marketProfessional testingReagent
Manufacturer
MRC Holland B.V.
Manufacturer SRN
NL-MF-000000437
UDI-DI
08720211481321
Basic UDI-DI
872021148P09569
Reference
P095-100R
EMDN
W0106010399
EMDN description
CHROMOSOMAL DISORDERS TESTS - OTHER
First on market country
-
Authorised representative
-
Last updated
07.08.2026 22:47
Manufacturer productsView details
TRUPCR® DPYD Mutations Detection Kit

TRUPCR® DPYD Mutations Detection Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent
Manufacturer
3B BlackBio Dx Limited
Manufacturer SRN
IN-MF-000023698
UDI-DI
08906213930023
Basic UDI-DI
89080153043B1429LJ
Reference
3B1429/C
EMDN
W01060299
EMDN description
TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country
Germany
Authorised representative
Wellkang Ltd
Last updated
07.08.2026 20:47
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
HLA B5701 Strip

3.155.XXX.YY.ZZZ

IVD Class CIVDR 2017/746On the marketAnimal tissuesCompanion diagnosticsKitProfessional testingReagent
Manufacturer
OPERON, S.A.
Manufacturer SRN
ES-MF-000004790
UDI-DI
08429577002903
Basic UDI-DI
84295773155WV
Reference
3.155.016.53.000
EMDN
W0106010401
EMDN description
HLA-TYPING
First on market country
Spain
Safety summary (SSCP/SSP)
DO-040131 HLA B5701 Strip · Rev. 02
Authorised representative
-
Last updated
07.08.2026 13:40
Manufacturer productsOpen in EUDAMEDView details
HLA B5701 Strip

-

IVD Class CIVDR 2017/746On the marketAnimal tissuesCompanion diagnosticsKitProfessional testingReagent
Manufacturer
OPERON, S.A.
Manufacturer SRN
ES-MF-000004790
UDI-DI
08429577002910
Basic UDI-DI
84295773155WV
Reference
3.155.048.53.000
EMDN
W0106010401
EMDN description
HLA-TYPING
First on market country
-
Safety summary (SSCP/SSP)
DO-040131 HLA B5701 Strip · Rev. 02
Authorised representative
-
Last updated
07.08.2026 13:37
Manufacturer productsOpen in EUDAMEDView details