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D-06971808258129VJ

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000033113
UDI-DI: D-06971808258129VJ
Basic UDI-DI: B-06971808258129VJ
Reference: FP-014-2
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: 06.08.2026 07:07

Manufacturer products Authorised representative products Authorised representative actors View details

D-06971808256804VP

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000033113
UDI-DI: D-06971808256804VP
Basic UDI-DI: B-06971808256804VP
Reference: FP-014-1
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: 06.08.2026 07:07

Manufacturer products Authorised representative products Authorised representative actors View details

06971808257719

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: 06971808257719
Basic UDI-DI: B-06971808257719
Reference: FP-011-2
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: 06.08.2026 06:59

Manufacturer products Authorised representative products Authorised representative actors View details

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

SALSA MLPA Probemix P082 NF1 mix 2

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: MRC Holland B.V.
Manufacturer SRN: NL-MF-000000437
UDI-DI: 08720211481093
Basic UDI-DI: 872021148P0825Y
Reference: P082-025R
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 05.08.2026 23:04

Manufacturer products View details

SALSA MLPA Probemix P082 NF1 mix 2

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: MRC Holland B.V.
Manufacturer SRN: NL-MF-000000437
UDI-DI: 08720211481109
Basic UDI-DI: 872021148P0825Y
Reference: P082-050R
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 05.08.2026 22:50

Manufacturer products View details

SALSA MLPA Probemix P082 NF1 mix 2

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: MRC Holland B.V.
Manufacturer SRN: NL-MF-000000437
UDI-DI: 08720211481116
Basic UDI-DI: 872021148P0825Y
Reference: P082-100R
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 05.08.2026 22:50

Manufacturer products View details

37350134361794

SPOT-it TREC, KREC & SMN1 Screening Kit

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: ImmunoIVD AB
Manufacturer SRN: SE-MF-000034517
UDI-DI: 37350134361794
Basic UDI-DI: 7350134361799E
Reference: 4-2020-TKS
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 05.08.2026 16:34

Manufacturer products View details

37350134361183

SPOT-it TREC & KREC Screening Kit

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: ImmunoIVD AB
Manufacturer SRN: SE-MF-000034517
UDI-DI: 37350134361183
Basic UDI-DI: 7350134361188S
Reference: 4-2015-TK
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 05.08.2026 16:34

Manufacturer products View details

37350134361176

SPOT-it TREC Screening Kit

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: ImmunoIVD AB
Manufacturer SRN: SE-MF-000034517
UDI-DI: 37350134361176
Basic UDI-DI: 7350134361178Q
Reference: 4-2015-T
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 05.08.2026 16:34

Manufacturer products View details

Detection Kit for Human MTHFR Gene Polymorphism (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: SINGUWAY BIOTECH INC.
Manufacturer SRN: CN-MF-000027180
UDI-DI: 06974081870781
Basic UDI-DI: B-06974081870781
Reference: MTHFR
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Greece
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 05.08.2026 14:44

Manufacturer products Authorised representative products Authorised representative actors View details

K019-FactorV / Prothrombin

K019-Factor V / Prothrombin

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Genekam Biotechnology AG
Manufacturer SRN: DE-MF-000035227
UDI-DI: 04262420430409
Basic UDI-DI: B-04262420430409
Reference: K019
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 12:44

Manufacturer products View details

HPA-FluoGene 1a/b Screen

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: inno-train Diagnostik GmbH
Manufacturer SRN: DE-MF-000024702
UDI-DI: 04260152483830
Basic UDI-DI: B-04260152483830
Reference: 003 011 048
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 11:14

Manufacturer products View details

RBC-FluoGene ABO basic

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: inno-train Diagnostik GmbH
Manufacturer SRN: DE-MF-000024702
UDI-DI: 04260152483779
Basic UDI-DI: B-04260152483779
Reference: 001 086 010
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 11:14

Manufacturer products View details

HPA-FluoGene NX

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: inno-train Diagnostik GmbH
Manufacturer SRN: DE-MF-000024702
UDI-DI: 04260152483458
Basic UDI-DI: B-04260152483458
Reference: 003 015 048
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 11:14

Manufacturer products View details

HPA-FluoGene NX

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: inno-train Diagnostik GmbH
Manufacturer SRN: DE-MF-000024702
UDI-DI: 04260152483441
Basic UDI-DI: B-04260152483441
Reference: 003 015 010
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 11:14

Manufacturer products View details