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40 device results listed.

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SULFOLYSER

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 04987562510948
Basic UDI-DI: 4987562SULFOLYSERBV
Reference: 904-1141-4
EMDN: W0103010504
EMDN description: HAEMOGLOBIN CONTROLS
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 31.07.2026 07:41

Manufacturer products Authorised representative products Authorised representative actors View details

D-HC-111ELTP

Hemoglobin A2 elevated control

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Seleo S.r.l.
Manufacturer SRN: IT-MF-000045668
UDI-DI: D-HC-111ELTP
Basic UDI-DI: B-HC-111ELTP
Reference: HC-111EL
EMDN: W0103010504
EMDN description: HAEMOGLOBIN CONTROLS
First on market country: Italy
Authorised representative: -
Last updated: 14.07.2026 00:53

Manufacturer products View details

D-HC-102ZU

AFSC Haemoglobin control

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Seleo S.r.l.
Manufacturer SRN: IT-MF-000045668
UDI-DI: D-HC-102ZU
Basic UDI-DI: B-HC-102ZU
Reference: HC-102
EMDN: W0103010504
EMDN description: HAEMOGLOBIN CONTROLS
First on market country: Italy
Authorised representative: -
Last updated: 14.07.2026 00:53

Manufacturer products View details

D-HC-111ZV

Hemoglobin A2 normal control

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Seleo S.r.l.
Manufacturer SRN: IT-MF-000045668
UDI-DI: D-HC-111ZV
Basic UDI-DI: B-HC-111ZV
Reference: HC-111
EMDN: W0103010504
EMDN description: HAEMOGLOBIN CONTROLS
First on market country: Italy
Authorised representative: -
Last updated: 14.07.2026 00:53

Manufacturer products View details

HemoTrol Duo High

IVD generalIVDDOn the marketAnimal tissuesNear-patient testingProfessional testing

Manufacturer: Eurotrol B.V.
Manufacturer SRN: NL-MF-000005790
UDI-DI: D-AN01637A032A
Basic UDI-DI: B-AN01637A032A
Reference: AN01637A03
EMDN: W0103010504
EMDN description: HAEMOGLOBIN CONTROLS
First on market country: Netherlands
Authorised representative: -
Last updated: 12.07.2026 21:35

Manufacturer products View details

HemoTrol Duo Normal

IVD generalIVDDOn the marketAnimal tissuesNear-patient testingProfessional testing

Manufacturer: Eurotrol B.V.
Manufacturer SRN: NL-MF-000005790
UDI-DI: D-AN01637A0228
Basic UDI-DI: B-AN01637A0228
Reference: AN01637A02
EMDN: W0103010504
EMDN description: HAEMOGLOBIN CONTROLS
First on market country: Netherlands
Authorised representative: -
Last updated: 12.07.2026 21:35

Manufacturer products View details

HemoTrol Duo Low

IVD generalIVDDOn the marketAnimal tissuesNear-patient testingProfessional testing

Manufacturer: Eurotrol B.V.
Manufacturer SRN: NL-MF-000005790
UDI-DI: D-AN01637A0126
Basic UDI-DI: B-AN01637A0126
Reference: AN01637A01
EMDN: W0103010504
EMDN description: HAEMOGLOBIN CONTROLS
First on market country: Netherlands
Authorised representative: -
Last updated: 12.07.2026 21:35

Manufacturer products View details

HbDIL DxC

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-A88469XF
Basic UDI-DI: B-A88469XF
Reference: A88469
EMDN: W0103010504
EMDN description: HAEMOGLOBIN CONTROLS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 12.07.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

HemoTrol High (Level 3)

IVD generalIVDDOn the marketAnimal tissuesNear-patient testingProfessional testing

Manufacturer: Eurotrol B.V.
Manufacturer SRN: NL-MF-000005790
UDI-DI: D-202.003.00265
Basic UDI-DI: B-202.003.00265
Reference: 202.003.002
EMDN: W0103010504
EMDN description: HAEMOGLOBIN CONTROLS
First on market country: Netherlands
Authorised representative: -
Last updated: 11.07.2026 14:27

Manufacturer products View details

HemoTrol Normal (Level 2)

IVD generalIVDDOn the marketAnimal tissuesNear-patient testingProfessional testing

Manufacturer: Eurotrol B.V.
Manufacturer SRN: NL-MF-000005790
UDI-DI: D-202.002.0025S
Basic UDI-DI: B-202.002.0025S
Reference: 202.002.002
EMDN: W0103010504
EMDN description: HAEMOGLOBIN CONTROLS
First on market country: Netherlands
Authorised representative: -
Last updated: 11.07.2026 14:27

Manufacturer products View details

HemoTrol Low (Level 1)

IVD generalIVDDOn the marketAnimal tissuesNear-patient testingProfessional testing

Manufacturer: Eurotrol B.V.
Manufacturer SRN: NL-MF-000005790
UDI-DI: D-202.001.0025F
Basic UDI-DI: B-202.001.0025F
Reference: 202.001.002
EMDN: W0103010504
EMDN description: HAEMOGLOBIN CONTROLS
First on market country: Netherlands
Authorised representative: -
Last updated: 11.07.2026 14:27

Manufacturer products View details

Hb 301 Control High

IVD generalIVDDOn the marketAnimal tissuesNear-patient testingProfessional testing

Manufacturer: Eurotrol B.V.
Manufacturer SRN: NL-MF-000005790
UDI-DI: D-147.003.002CD
Basic UDI-DI: B-147.003.002CD
Reference: 147.003.002
EMDN: W0103010504
EMDN description: HAEMOGLOBIN CONTROLS
First on market country: Netherlands
Authorised representative: -
Last updated: 11.07.2026 08:18

Manufacturer products View details

Hb 301 Control Normal

IVD generalIVDDOn the marketAnimal tissuesNear-patient testingProfessional testing

Manufacturer: Eurotrol B.V.
Manufacturer SRN: NL-MF-000005790
UDI-DI: D-147.002.002C2
Basic UDI-DI: B-147.002.002C2
Reference: 147.002.002
EMDN: W0103010504
EMDN description: HAEMOGLOBIN CONTROLS
First on market country: Netherlands
Authorised representative: -
Last updated: 11.07.2026 08:18

Manufacturer products View details

Hb 301 Control Low

IVD generalIVDDOn the marketAnimal tissuesNear-patient testingProfessional testing

Manufacturer: Eurotrol B.V.
Manufacturer SRN: NL-MF-000005790
UDI-DI: D-147.001.002BP
Basic UDI-DI: B-147.001.002BP
Reference: 147.001.002
EMDN: W0103010504
EMDN description: HAEMOGLOBIN CONTROLS
First on market country: Netherlands
Authorised representative: -
Last updated: 11.07.2026 08:18

Manufacturer products View details

extendSURETM Haemoglobin F and A2 Calibrators

HB110SCALAr

IVD generalIVDDOn the marketHuman tissuesKit

Manufacturer: Canterbury Scientific Limited
Manufacturer SRN: NZ-MF-000001778
UDI-DI: 09421902348044
Basic UDI-DI: B-09421902348044
Reference: HB110SCALAr
EMDN: W0103010504
EMDN description: HAEMOGLOBIN CONTROLS
First on market country: Northern Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 10.07.2026 23:51

Manufacturer products Authorised representative products Authorised representative actors View details

extendSURE™ Haemoglobin F and A2 Controls

HB110SSBAr

IVD generalIVDDOn the marketHuman tissuesKit

Manufacturer: Canterbury Scientific Limited
Manufacturer SRN: NZ-MF-000001778
UDI-DI: 09421902348037
Basic UDI-DI: B-09421902348037
Reference: HB110SSBAr
EMDN: W0103010504
EMDN description: HAEMOGLOBIN CONTROLS
First on market country: Northern Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 10.07.2026 23:51

Manufacturer products Authorised representative products Authorised representative actors View details

CERA-CHEK™ 3 in 1 GHL Hemoglobin Control Solution

M 400

IVD Annex II List BIVDDOn the marketNear-patient testingSelf testing

Manufacturer: GC MEDIS Corp.
Manufacturer SRN: KR-MF-000012638
UDI-DI: 08800065170203
Basic UDI-DI: B-08800065170203
Reference: M400C11
EMDN: W0103010504
EMDN description: HAEMOGLOBIN CONTROLS
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 05:12

Manufacturer products Authorised representative products Authorised representative actors View details

CERA-CHEK™ Hb Plus Hemoglobin Control Solution

H 400

IVD self-testing devicesIVDDOn the marketNear-patient testingProfessional testingReagentSelf testing

Manufacturer: GC MEDIS Corp.
Manufacturer SRN: KR-MF-000012638
UDI-DI: 08800065170005
Basic UDI-DI: B-08800065170005
Reference: B400C10
EMDN: W0103010504
EMDN description: HAEMOGLOBIN CONTROLS
First on market country: Romania
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 05:12

Manufacturer products Authorised representative products Authorised representative actors View details

AllDx

CS105

IVD generalIVDDOn the marketNear-patient testingProfessional testingReagent

Manufacturer: Hangzhou Aokai Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000048311
UDI-DI: 06978467910214
Basic UDI-DI: B-06978467910214
Reference: CS105-0011
EMDN: W0103010504
EMDN description: HAEMOGLOBIN CONTROLS
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 07.07.2026 01:44

Manufacturer products Authorised representative products Authorised representative actors View details

ß-THALASSAEMIA & HbA1c Control Material

The kit includes Control Material Level 1, Level 2, 2×0.1mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06978139078327
Basic UDI-DI: B-06978139078327
Reference: 56150
EMDN: W0103010504
EMDN description: HAEMOGLOBIN CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.07.2026 01:41

Manufacturer products Authorised representative products Authorised representative actors View details