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HHV8 ELITe MGB® Kit

IVD Class CIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: ElitechGroup S.p.A.
Manufacturer SRN: IT-MF-000005919
UDI-DI: 08033891483968
Basic UDI-DI: 803389148HHV25CP
Reference: RTS038PLD
EMDN: W0105040524
EMDN description: HHV-6,7,8 - NA REAGENTS
First on market country: Italy
Authorised representative: -
Last updated: 24.09.2026 07:11

Manufacturer products View details

HHV6 - ELITe Positive Control

HHV6 ELITe MGB® Kit

IVD Class CIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: ElitechGroup S.p.A.
Manufacturer SRN: IT-MF-000005919
UDI-DI: 08033891483517
Basic UDI-DI: 803389148HHV39D2
Reference: CTR036PLD
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Italy
Authorised representative: -
Last updated: 24.09.2026 07:11

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AMPLIQUALITY HCV TYPE PLUS

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

Manufacturer: AB ANALITICA srl
Manufacturer SRN: IT-MF-000032625
UDI-DI: 08033622784470
Basic UDI-DI: 803362278AINFrk00000000T5
Reference: 03-05-XX
EMDN: W0105020309
EMDN description: HEPATITIS C VIRUS (HCV) GENOTYPING - NA REAGENTS
First on market country: Italy
Authorised representative: -
Last updated: 24.09.2026 07:11

Manufacturer products View details

Fast Fluorescence In Situ Hybridization Probe Kit

MYC(8q24)/BCL6(3q27)/BCL2(18q21) gene break apart probe reagent

IVD Class CIVDR 2017/746On the marketMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000033113
UDI-DI: 06971808257429
Basic UDI-DI: 697180825KFP243HN
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: 24.09.2026 06:53

Manufacturer products Authorised representative products Authorised representative actors View details

BD LEUCOCOUNT

BD Leucocount Control

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Becton, Dickinson and Company, BD Biosciences
Manufacturer SRN: US-MF-000017797
UDI-DI: 00382903410019
Basic UDI-DI: 038290BDMJNRFX3Z
Reference: 341001
EMDN: W0103080402
EMDN description: LEUCOCYTE CONTROLS
First on market country: Belgium
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 24.09.2026 06:49

Manufacturer products Authorised representative products Authorised representative actors View details

BD MULTI-CHECK

BD Multi-Check Controls

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Becton, Dickinson and Company, BD Biosciences
Manufacturer SRN: US-MF-000017797
UDI-DI: 00382903409112
Basic UDI-DI: 038290DYCWQUCGGJ
Reference: 340911
EMDN: W0103080403
EMDN description: LYMPHOCYTE SUBTYPING CONTROLS
First on market country: Belgium
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 24.09.2026 06:49

Manufacturer products Authorised representative products Authorised representative actors View details

BD LEUCOCOUNT

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Becton, Dickinson and Company, BD Biosciences
Manufacturer SRN: US-MF-000017797
UDI-DI: 00382903410033
Basic UDI-DI: 038290BDMJNRFX3Z
Reference: 341003
EMDN: W0103080402
EMDN description: LEUCOCYTE CONTROLS
First on market country: -
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 24.09.2026 06:39

Manufacturer products Authorised representative products Authorised representative actors View details

BD MULTI-CHECK

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Becton, Dickinson and Company, BD Biosciences
Manufacturer SRN: US-MF-000017797
UDI-DI: 00382903409129
Basic UDI-DI: 038290DYCWQUCGGJ
Reference: 340912
EMDN: W0103080403
EMDN description: LYMPHOCYTE SUBTYPING CONTROLS
First on market country: -
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 24.09.2026 06:39

Manufacturer products Authorised representative products Authorised representative actors View details

BD LEUCOCOUNT

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Becton, Dickinson and Company, BD Biosciences
Manufacturer SRN: US-MF-000017797
UDI-DI: 00382903410026
Basic UDI-DI: 038290BDMJNRFX3Z
Reference: 341002
EMDN: W0103080402
EMDN description: LEUCOCYTE CONTROLS
First on market country: -
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 24.09.2026 06:39

Manufacturer products Authorised representative products Authorised representative actors View details

BD MULTI-CHECK

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Becton, Dickinson and Company, BD Biosciences
Manufacturer SRN: US-MF-000017797
UDI-DI: 00382903409136
Basic UDI-DI: 038290DYCWQUCGGJ
Reference: 340913
EMDN: W0103080403
EMDN description: LYMPHOCYTE SUBTYPING CONTROLS
First on market country: -
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 24.09.2026 06:39

Manufacturer products Authorised representative products Authorised representative actors View details

Fast Fluorescence In Situ Hybridization Probe Kit

IVD Class CIVDR 2017/746On the marketMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000033113
UDI-DI: 06971808258440
Basic UDI-DI: 697180825KFP243HN
Reference: FP-243-3
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: -
Authorised representative: Kingsmead Service B.V.
Last updated: 24.09.2026 06:38

Manufacturer products Authorised representative products Authorised representative actors View details

DyonStrepA Strep A Rapid Test

Strep A Rapid Test

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSelf testingSingle use

Manufacturer: GenSure Biotech Inc.
Manufacturer SRN: CN-MF-000028354
UDI-DI: 06976838234891
Basic UDI-DI: 697683823P201900F9
Reference: P2019C01
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Greece
Safety summary (SSCP/SSP): GS/TD-EU-P2019-901 · Rev. A/2
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 24.09.2026 06:32

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Substrate Solution

Please see UDI-DIs for details

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Guangzhou KOFA Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045346
UDI-DI: 06974576205821
Basic UDI-DI: 697457620FGSS01PX
Reference: GFQXY00A
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Romania
Authorised representative: Medunion S.L.
Last updated: 24.09.2026 06:22

Manufacturer products Authorised representative products Authorised representative actors View details

Ovulation testing kits

IVD self-testing devicesNot specifiedOn the marketSingle use

Manufacturer: Nantong Diagnos Biotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000041526
UDI-DI: 06934592100098
Basic UDI-DI: B-06934592100098
Reference: AE67
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Germany
Authorised representative: Kingsmead Service B.V.
Last updated: 24.09.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

06941967233985

TH-PClean

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967233985
Basic UDI-DI: 69732628600103ZH
Reference: 1301111
EMDN: W0103020903
EMDN description: BUFFERS (HAEMOSTASIS)
First on market country: Netherlands
Authorised representative: QbD RepS BV
Last updated: 24.09.2026 06:10

Manufacturer products Authorised representative products Authorised representative actors View details

06941967233954

Diluent

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967233954
Basic UDI-DI: 69732628600102ZF
Reference: 1301209
EMDN: W0103020903
EMDN description: BUFFERS (HAEMOSTASIS)
First on market country: Netherlands
Authorised representative: QbD RepS BV
Last updated: 24.09.2026 06:10

Manufacturer products Authorised representative products Authorised representative actors View details

06941967233909

Anti-Xa Controls

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967233909
Basic UDI-DI: 697326286000942C
Reference: 1302303
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Netherlands
Authorised representative: QbD RepS BV
Last updated: 24.09.2026 06:10

Manufacturer products Authorised representative products Authorised representative actors View details

06941967233879

Anti-Xa Reagent Kit (Chromogenic Substrate Method)

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967233879
Basic UDI-DI: 697326286000932A
Reference: 1301902
EMDN: W0103020303
EMDN description: STANDARD HEPARIN
First on market country: Netherlands
Authorised representative: QbD RepS BV
Last updated: 24.09.2026 06:10

Manufacturer products Authorised representative products Authorised representative actors View details

Fast Fluorescence In Situ Hybridization Probe Kit

FGFR1/PDGFRA/PDGFRB gene break apart probe reagent

IVD Class CIVDR 2017/746On the marketMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000033113
UDI-DI: 06971808257375
Basic UDI-DI: 697180825KFP232HH
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: 24.09.2026 06:01

Manufacturer products Authorised representative products Authorised representative actors View details

Fast Fluorescence In Situ Hybridization Probe Kit

NTRK1/NTRK2/NTRK3 gene break apart probe reagent

IVD Class CIVDR 2017/746On the marketMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000033113
UDI-DI: 06971808257368
Basic UDI-DI: 697180825KFP231HF
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: 24.09.2026 06:01

Manufacturer products Authorised representative products Authorised representative actors View details