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135 device results listed.

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vW Abnormal Control Plasma

IVD Class AIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Bio/Data Corporation
Manufacturer SRN: US-MF-000026991
UDI-DI: *+G0561012701/ $$0100058XXXXXX*
Basic UDI-DI: ++G0561012703E
Reference: 101270
EMDN: W01030199
EMDN description: HAEMATOLOGY REAGENTS - OTHER
First on market country: Italy
Authorised representative: mdi Europa GmbH
Last updated: 15.07.2026 19:18

Manufacturer products Authorised representative products Authorised representative actors View details

vW Normal Reference Plasma

IVD Class AIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Bio/Data Corporation
Manufacturer SRN: US-MF-000026991
UDI-DI: *+G0561012691/ $$0100057XXXX7*
Basic UDI-DI: ++G0561012693V
Reference: 101269
EMDN: W01030199
EMDN description: HAEMATOLOGY REAGENTS - OTHER
First on market country: Italy
Authorised representative: mdi Europa GmbH
Last updated: 15.07.2026 19:18

Manufacturer products Authorised representative products Authorised representative actors View details

AggRecetin Reagent

AggRecetin Reagent (Ristocetin A Sulfate)

IVD Class AIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Bio/Data Corporation
Manufacturer SRN: US-MF-000026991
UDI-DI: *+G0561012410/ $$0124065XXXX1*
Basic UDI-DI: ++G05610124137
Reference: 101241
EMDN: W01030199
EMDN description: HAEMATOLOGY REAGENTS - OTHER
First on market country: Italy
Authorised representative: mdi Europa GmbH
Last updated: 15.07.2026 19:18

Manufacturer products Authorised representative products Authorised representative actors View details

Sodium Citrate (0.11 M)

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Bio/Data Corporation
Manufacturer SRN: US-MF-000026991
UDI-DI: *+G0561009940/ $$0100022XXXXXZ*
Basic UDI-DI: ++G0561009944Q
Reference: 100994
EMDN: W01030199
EMDN description: HAEMATOLOGY REAGENTS - OTHER
First on market country: Italy
Authorised representative: mdi Europa GmbH
Last updated: 15.07.2026 19:18

Manufacturer products Authorised representative products Authorised representative actors View details

TRIS Buffered Saline

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Bio/Data Corporation
Manufacturer SRN: US-MF-000026991
UDI-DI: *+G0561009910/ $$0100137XXXXX$*
Basic UDI-DI: ++G0561009914J
Reference: 100991
EMDN: W01030199
EMDN description: HAEMATOLOGY REAGENTS - OTHER
First on market country: Italy
Authorised representative: mdi Europa GmbH
Last updated: 15.07.2026 19:18

Manufacturer products Authorised representative products Authorised representative actors View details

Calcium Chloride Solution (0.025 M)

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Bio/Data Corporation
Manufacturer SRN: US-MF-000026991
UDI-DI: *+G0561009891/ $$0100025XXXXX%*
Basic UDI-DI: ++G0561009894X
Reference: 100989
EMDN: W01030199
EMDN description: HAEMATOLOGY REAGENTS - OTHER
First on market country: Italy
Authorised representative: mdi Europa GmbH
Last updated: 15.07.2026 19:18

Manufacturer products Authorised representative products Authorised representative actors View details

AggRecetin Reagent

AggRecetin Reagent (Ristocetin A Sulfate)

IVD Class AIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Bio/Data Corporation
Manufacturer SRN: US-MF-000026991
UDI-DI: *+G0561009700/ $$042603600562M*
Basic UDI-DI: ++G0561009704A
Reference: 100970
EMDN: W01030199
EMDN description: HAEMATOLOGY REAGENTS - OTHER
First on market country: Italy
Authorised representative: mdi Europa GmbH
Last updated: 15.07.2026 19:18

Manufacturer products Authorised representative products Authorised representative actors View details

AAV5 NAb Test

C2201301EU

IVD generalIVDDOn the marketCompanion diagnosticsMicrobial substancesProfessional testingSingle use

Manufacturer: Precision for Medicine, Inc.
Manufacturer SRN: US-MF-000007346
UDI-DI: 00860006973537
Basic UDI-DI: B-00860006973537
Reference: CC201301EU
EMDN: W01030199
EMDN description: HAEMATOLOGY REAGENTS - OTHER
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 05.07.2026 11:45

Manufacturer products Authorised representative products Authorised representative actors View details

LOWY ROZTOK

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect markingReagentSingle use

Manufacturer: Ing. Petr Švec - PENTA s.r.o.
Manufacturer SRN: CZ-MF-000035988
UDI-DI: 08595142250502
Basic UDI-DI: 85951422209407T
Reference: 20940-11000
EMDN: W01030199
EMDN description: HAEMATOLOGY REAGENTS - OTHER
First on market country: Czechia
Authorised representative: -
Last updated: 03.07.2026 16:55

Manufacturer products View details

KYSELINA PIKROVÁ nasycený vodný roztok

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect markingProfessional testingReagentSingle use

Manufacturer: Ing. Petr Švec - PENTA s.r.o.
Manufacturer SRN: CZ-MF-000035988
UDI-DI: 08595142243009
Basic UDI-DI: 85951422201106A
Reference: 20110-11000
EMDN: W01030199
EMDN description: HAEMATOLOGY REAGENTS - OTHER
First on market country: Czechia
Authorised representative: -
Last updated: 03.07.2026 16:54

Manufacturer products View details

HAYEM ROZTOK

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect markingReagentSingle use

Manufacturer: Ing. Petr Švec - PENTA s.r.o.
Manufacturer SRN: CZ-MF-000035988
UDI-DI: 08595142233413
Basic UDI-DI: 85951422147107R
Reference: 14710
EMDN: W01030199
EMDN description: HAEMATOLOGY REAGENTS - OTHER
First on market country: Czechia
Authorised representative: -
Last updated: 03.07.2026 16:54

Manufacturer products View details

TÜRK (1 x 500mL)

TÜRK

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: QUIMICA CLINICA APLICADA S.A.
Manufacturer SRN: ES-MF-000001512
UDI-DI: 08430155006084
Basic UDI-DI: 8430155TURK75
Reference: 996972
EMDN: W01030199
EMDN description: HAEMATOLOGY REAGENTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:21

Manufacturer products View details

HAYEM (1 x 500mL)

HAYEM’S SOLUTION

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: QUIMICA CLINICA APLICADA S.A.
Manufacturer SRN: ES-MF-000001512
UDI-DI: 08430155005889
Basic UDI-DI: 8430155HAYEMUR
Reference: 991528
EMDN: W01030199
EMDN description: HAEMATOLOGY REAGENTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:18

Manufacturer products View details

Anticoagulante W

IVD Class AIVDR 2017/746No longer on the marketProfessional testingReagent

Manufacturer: Wiener Laboratorios SAIC
Manufacturer SRN: AR-MF-000023605
UDI-DI: 07798100043241
Basic UDI-DI: 7798100041898552P5
Reference: 1898552
EMDN: W01030199
EMDN description: HAEMATOLOGY REAGENTS - OTHER
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 07:09

Manufacturer products Authorised representative products Authorised representative actors View details

Diluent CD

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

Manufacturer: Labex Reagens AB
Manufacturer SRN: SE-MF-000048594
UDI-DI: 07350145000001
Basic UDI-DI: 73501450010011001SJ
Reference: DI001
EMDN: W01030199
EMDN description: HAEMATOLOGY REAGENTS - OTHER
First on market country: Bulgaria
Authorised representative: -
Last updated: 03.07.2026 05:06

Manufacturer products View details

06979822870174

Sample Separation Media

IVD Class AIVDR 2017/746On the marketKitReagent

Manufacturer: Cellomics (Shenzhen) Limited
Manufacturer SRN: CN-MF-000028334
UDI-DI: 06979822870174
Basic UDI-DI: 697982287CTCP0007GF
Reference: CTCP0007
EMDN: W01030199
EMDN description: HAEMATOLOGY REAGENTS - OTHER
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 03.07.2026 00:47

Manufacturer products Authorised representative products Authorised representative actors View details

06979822870167

Sample Separation Media

IVD Class AIVDR 2017/746On the marketKitReagent

Manufacturer: Cellomics (Shenzhen) Limited
Manufacturer SRN: CN-MF-000028334
UDI-DI: 06979822870167
Basic UDI-DI: 697982287CTCP0006GD
Reference: CTCP0006
EMDN: W01030199
EMDN description: HAEMATOLOGY REAGENTS - OTHER
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 03.07.2026 00:47

Manufacturer products Authorised representative products Authorised representative actors View details

06979822870082

Sample Separation Media

IVD Class AIVDR 2017/746On the marketKitReagent

Manufacturer: Cellomics (Shenzhen) Limited
Manufacturer SRN: CN-MF-000028334
UDI-DI: 06979822870082
Basic UDI-DI: 697982287CTCP0003G7
Reference: CTCP0003
EMDN: W01030199
EMDN description: HAEMATOLOGY REAGENTS - OTHER
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 03.07.2026 00:47

Manufacturer products Authorised representative products Authorised representative actors View details

06941967224600

H56 LD-II

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967224600
Basic UDI-DI: 697326286000592A
Reference: 01.09.31.03.03.02
EMDN: W01030199
EMDN description: HAEMATOLOGY REAGENTS - OTHER
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details

06941967224594

H56 LD-I

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967224594
Basic UDI-DI: 6973262860005828
Reference: 01.09.31.03.02.02
EMDN: W01030199
EMDN description: HAEMATOLOGY REAGENTS - OTHER
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details