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Active filter:Manufacturer SRN:CN-MF-000033113

89 device results listed.

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D-697180825KFP009HCWE

Bladder Cancer Cells 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-697180825KFP009HCWE
Basic UDI-DI: B-697180825KFP009HCWE
Reference: FP-009
EMDN: W01060215
EMDN description: BLADDER CANCER DETECTION / MONITORING
First on market country: Czechia
Authorised representative: Kingsmead Service B.V.
Last updated: 06.08.2026 01:31

Manufacturer products Authorised representative products Authorised representative actors View details

D-697180825KFP005H4UW

RARA (17q21) probe reagent

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000033113
UDI-DI: D-697180825KFP005H4UW
Basic UDI-DI: B-697180825KFP005H4UW
Reference: FP-005
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 01:31

Manufacturer products Authorised representative products Authorised representative actors View details

D-697180825KFP004H2UM

AML1/ETO gene fusion detection kit

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000033113
UDI-DI: D-697180825KFP004H2UM
Basic UDI-DI: B-697180825KFP004H2UM
Reference: FP-004
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 01:31

Manufacturer products Authorised representative products Authorised representative actors View details

D-697180825KFP001GUW7

Human HER2 gene amplification detection kit

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000033113
UDI-DI: D-697180825KFP001GUW7
Basic UDI-DI: B-697180825KFP001GUW7
Reference: FP-001
EMDN: W01060213
EMDN description: HER-2/NEU (BREAST CANCER)
First on market country: Czechia
Authorised representative: Kingsmead Service B.V.
Last updated: 06.08.2026 01:31

Manufacturer products Authorised representative products Authorised representative actors View details

D-697180825KCL003F3R5

BCR/ABL gene fusion detection kit

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000033113
UDI-DI: D-697180825KCL003F3R5
Basic UDI-DI: B-697180825KCL003F3R5
Reference: FP-003
EMDN: W01060208
EMDN description: T (9;22)
First on market country: Czechia
Authorised representative: Kingsmead Service B.V.
Last updated: 06.08.2026 01:31

Manufacturer products Authorised representative products Authorised representative actors View details

06971808258266

Washing Solution

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000033113
UDI-DI: 06971808258266
Basic UDI-DI: 697180825KCL009FF
Reference: FP-007
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: Czechia
Authorised representative: Kingsmead Service B.V.
Last updated: 31.07.2026 21:21

Manufacturer products Authorised representative products Authorised representative actors View details

06971808258273

Washing Solution

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000033113
UDI-DI: 06971808258273
Basic UDI-DI: 697180825KCL009FF
Reference: CL-009-6
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: Czechia
Authorised representative: Kingsmead Service B.V.
Last updated: 27.07.2026 01:58

Manufacturer products Authorised representative products Authorised representative actors View details

06971808256231

Washing Solution

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000033113
UDI-DI: 06971808256231
Basic UDI-DI: 697180825KCL009FF
Reference: CL-009-11
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: Czechia
Authorised representative: Kingsmead Service B.V.
Last updated: 21.07.2026 23:05

Manufacturer products Authorised representative products Authorised representative actors View details

Fast Fluorescence In Situ Hybridization Probe Kit

MYC(8q24)/BCL6(3q27)/BCL2(18q21) 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-06971808258440VM
Basic UDI-DI: B-06971808258440VM
Reference: FP-243-3
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: 16.07.2026 19:08

Manufacturer products Authorised representative products Authorised representative actors View details

Fast Fluorescence In Situ Hybridization Probe Kit

CCND1 (BCL1) 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-06971808257788WR
Basic UDI-DI: B-06971808257788WR
Reference: FP-042
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: 16.07.2026 19:08

Manufacturer products Authorised representative products Authorised representative actors View details

Fast Fluorescence In Situ Hybridization Probe Kit

1p/19q deletion probe reagent

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000033113
UDI-DI: D-06971808257672W5
Basic UDI-DI: B-06971808257672W5
Reference: FP-045
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: 16.07.2026 19:08

Manufacturer products Authorised representative products Authorised representative actors View details

Fast Fluorescence In Situ Hybridization Probe Kit

MYC (8q24)/BCL6 (3q27)/BCL2 (18q21) 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-06971808257634VV
Basic UDI-DI: B-06971808257634VV
Reference: FP-243-1
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: 16.07.2026 19:08

Manufacturer products Authorised representative products Authorised representative actors View details

Fast Fluorescence In Situ Hybridization Probe Kit

MYC(8q24)/BCL6(3q27)/BCL2(18q21) 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-06971808257429VS
Basic UDI-DI: B-06971808257429VS
Reference: FP-243-2
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: 16.07.2026 19:08

Manufacturer products Authorised representative products Authorised representative actors View details

Fast Fluorescence In Situ Hybridization Probe Kit

MDM2 gene amplification probe reagent

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000033113
UDI-DI: D-06971808256996WT
Basic UDI-DI: B-06971808256996WT
Reference: FP-054
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: 16.07.2026 19:08

Manufacturer products Authorised representative products Authorised representative actors View details

Fast Fluorescence In Situ Hybridization Probe Kit

DDIT3 (12q13) gene rearrangement probe reagent

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000033113
UDI-DI: D-06971808256972WD
Basic UDI-DI: B-06971808256972WD
Reference: FP-052
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: 16.07.2026 19:08

Manufacturer products Authorised representative products Authorised representative actors View details

Fast Fluorescence In Situ Hybridization Probe Kit

6q probe reagent

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000033113
UDI-DI: D-06971808256774W7
Basic UDI-DI: B-06971808256774W7
Reference: FP-006
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: 06.07.2026 14:04

Manufacturer products Authorised representative products Authorised representative actors View details

Fast Fluorescence In Situ Hybridization Probe Kit

Human ALK gene fusion detection probe

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000033113
UDI-DI: D-06971808256378VT
Basic UDI-DI: B-06971808256378VT
Reference: FP-002
EMDN: W01060213
EMDN description: HER-2/NEU (BREAST CANCER)
First on market country: Czechia
Authorised representative: Kingsmead Service B.V.
Last updated: 06.07.2026 14:04

Manufacturer products Authorised representative products Authorised representative actors View details

06971808258624

FISH Sample Processing Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000033113
UDI-DI: 06971808258624
Basic UDI-DI: 697180825KCL020F3
Reference: CL-020
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: Czechia
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 12:17

Manufacturer products Authorised representative products Authorised representative actors View details

06971808258280

In Situ Hybridization Staining Solution

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000033113
UDI-DI: 06971808258280
Basic UDI-DI: 697180825KCL012F4
Reference: CL-012-1
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: Czechia
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 12:17

Manufacturer products Authorised representative products Authorised representative actors View details

06971808258235

In Situ Hybridization Protease

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000033113
UDI-DI: 06971808258235
Basic UDI-DI: 697180825KCL010EY
Reference: CL-010-1
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: Czechia
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 12:17

Manufacturer products Authorised representative products Authorised representative actors View details