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40 device results listed.

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HbA1c Control Material

The kit includes Control Material Level 1 and Level 2 2 × 0.1mL / vials

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06978139078303
Basic UDI-DI: B-06978139078303
Reference: 55605
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

HbA2 & HbF & HbA1c Control

HbA2 & HbF & HbA1c Control

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06977125152430
Basic UDI-DI: B-06977125152430
Reference: GHDDM2
EMDN: W0103010504
EMDN description: HAEMOGLOBIN CONTROLS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 01:11

Manufacturer products Authorised representative products Authorised representative actors View details

HbA2 & HbF & HbA1c Control

HbA2 & HbF & HbA1c Control

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06977125152423
Basic UDI-DI: B-06977125152423
Reference: GHDDM1
EMDN: W0103010504
EMDN description: HAEMOGLOBIN CONTROLS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 01:11

Manufacturer products Authorised representative products Authorised representative actors View details

HbA1c Level 1: 0.1ml×1; Level 2: 0.1ml×1

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagentSingle use

Manufacturer: B&E BIO-TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000023256
UDI-DI: 06972337852482
Basic UDI-DI: B-06972337852482
Reference: HbA1c Level 1: 0.1ml×1; Level 2: 0.1ml×1
EMDN: W0103010504
EMDN description: HAEMOGLOBIN CONTROLS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 14:49

Manufacturer products Authorised representative products Authorised representative actors View details

Plasma/Low Hb Control '20.0'

Plasma/Low Hb Control '20.0'

IVD generalIVDDOn the marketAnimal tissuesNear-patient testingProfessional testing

Manufacturer: Eurotrol B.V.
Manufacturer SRN: NL-MF-000005790
UDI-DI: D-053.003.0029F
Basic UDI-DI: B-053.003.0029F
Reference: 053.003.002
EMDN: W0103010504
EMDN description: HAEMOGLOBIN CONTROLS
First on market country: Netherlands
Authorised representative: -
Last updated: 06.07.2026 08:34

Manufacturer products View details

Plasma/Low Hb Control '5.0'

Plasma/Low Hb Control '5.0'

IVD generalIVDDOn the marketAnimal tissuesNear-patient testingProfessional testing

Manufacturer: Eurotrol B.V.
Manufacturer SRN: NL-MF-000005790
UDI-DI: D-053.002.00294
Basic UDI-DI: B-053.002.00294
Reference: 053.002.002
EMDN: W0103010504
EMDN description: HAEMOGLOBIN CONTROLS
First on market country: Netherlands
Authorised representative: -
Last updated: 06.07.2026 08:34

Manufacturer products View details

Plasma/Low Hb Control '1.0'

Plasma/Low Hb Control '1.0'

IVD generalIVDDOn the marketAnimal tissuesNear-patient testingProfessional testing

Manufacturer: Eurotrol B.V.
Manufacturer SRN: NL-MF-000005790
UDI-DI: D-053.001.0028R
Basic UDI-DI: B-053.001.0028R
Reference: 053.001.002
EMDN: W0103010504
EMDN description: HAEMOGLOBIN CONTROLS
First on market country: Netherlands
Authorised representative: -
Last updated: 06.07.2026 08:34

Manufacturer products View details

HemoTrol High (Level 3)

HemoTrol High (Level 3)

IVD generalIVDDOn the marketAnimal tissuesNear-patient testingProfessional testing

Manufacturer: Eurotrol B.V.
Manufacturer SRN: NL-MF-000005790
UDI-DI: D-022.003.0025Z
Basic UDI-DI: B-022.003.0025Z
Reference: 022.003.002
EMDN: W0103010504
EMDN description: HAEMOGLOBIN CONTROLS
First on market country: Netherlands
Authorised representative: -
Last updated: 05.07.2026 16:14

Manufacturer products View details

HemoTrol Normal (Level 2)

HemoTrol Normal (Level 2)

IVD generalIVDDOn the marketAnimal tissuesNear-patient testingProfessional testing

Manufacturer: Eurotrol B.V.
Manufacturer SRN: NL-MF-000005790
UDI-DI: D-022.002.0025N
Basic UDI-DI: B-022.002.0025N
Reference: 022.002.002
EMDN: W0103010504
EMDN description: HAEMOGLOBIN CONTROLS
First on market country: Netherlands
Authorised representative: -
Last updated: 05.07.2026 16:14

Manufacturer products View details

HemoTrol Low (Level 1)

HemoTrol Low (Level 1)

IVD generalIVDDOn the marketAnimal tissuesNear-patient testingProfessional testing

Manufacturer: Eurotrol B.V.
Manufacturer SRN: NL-MF-000005790
UDI-DI: D-022.001.0025B
Basic UDI-DI: B-022.001.0025B
Reference: 022.001.002
EMDN: W0103010504
EMDN description: HAEMOGLOBIN CONTROLS
First on market country: Netherlands
Authorised representative: -
Last updated: 05.07.2026 16:14

Manufacturer products View details

VALIDATE® HbA1c Test Set

605to

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000029697
UDI-DI: 00859110005944
Basic UDI-DI: B-00859110005944
Reference: 605to
EMDN: W0103010504
EMDN description: HAEMOGLOBIN CONTROLS
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 05.07.2026 11:42

Manufacturer products Authorised representative products Authorised representative actors View details

VALIDATE® HbA1c Test Set

605

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000029697
UDI-DI: 00859110005937
Basic UDI-DI: B-00859110005937
Reference: 605
EMDN: W0103010504
EMDN description: HAEMOGLOBIN CONTROLS
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 05.07.2026 11:42

Manufacturer products Authorised representative products Authorised representative actors View details

VALIDATE® HbA1c Test Set

605sa

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000029697
UDI-DI: 00850011135327
Basic UDI-DI: B-00850011135327
Reference: 605sa
EMDN: W0103010504
EMDN description: HAEMOGLOBIN CONTROLS
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 05.07.2026 10:58

Manufacturer products Authorised representative products Authorised representative actors View details

HMCT001

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: GenBody Inc.
Manufacturer SRN: KR-MF-000043626
UDI-DI: 08800076701205
Basic UDI-DI: 88000767HMCT001JN
Reference: HMCT001
EMDN: W0103010504
EMDN description: HAEMOGLOBIN CONTROLS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:28

Manufacturer products Authorised representative products Authorised representative actors View details

HbA1c Control Material

-

IVD generalNot specifiedOn the market

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06941377305876
Basic UDI-DI: B-06941377305876
Reference: XQ-0107-02
EMDN: W0103010504
EMDN description: HAEMOGLOBIN CONTROLS
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 25.06.2026 07:18

Manufacturer products Authorised representative products Authorised representative actors View details

Hemoglobin Monitoring control solution

-

IVD self-testing devicesNot specifiedOn the market

Manufacturer: Sejoy Biomedical Co., Ltd.
Manufacturer SRN: CN-MF-000008447
UDI-DI: 06939663973199
Basic UDI-DI: B-06939663973199
Reference: HC-101
EMDN: W0103010504
EMDN description: HAEMOGLOBIN CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 25.06.2026 02:04

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD generalNot specifiedOn the market

Manufacturer: Jiangsu Konsung Bio-Medical Science And Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000016839
UDI-DI: 06934822535553
Basic UDI-DI: B-06934822535553
Reference: Level H
EMDN: W0103010504
EMDN description: HAEMOGLOBIN CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 24.06.2026 12:58

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD generalNot specifiedOn the market

Manufacturer: Jiangsu Konsung Bio-Medical Science And Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000016839
UDI-DI: 06934822535546
Basic UDI-DI: B-06934822535546
Reference: Level M
EMDN: W0103010504
EMDN description: HAEMOGLOBIN CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 24.06.2026 12:58

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD generalNot specifiedOn the market

Manufacturer: Jiangsu Konsung Bio-Medical Science And Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000016839
UDI-DI: 06934822535539
Basic UDI-DI: B-06934822535539
Reference: Level L
EMDN: W0103010504
EMDN description: HAEMOGLOBIN CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 24.06.2026 12:57

Manufacturer products Authorised representative products Authorised representative actors View details

RESOLVE Hb FASC Control Kit

-

IVD generalNot specifiedOn the market

Manufacturer: Wallac Oy
Manufacturer SRN: FI-MF-000022620
UDI-DI: 06438147385478
Basic UDI-DI: B-06438147385478
Reference: 3412-0010
EMDN: W0103010504
EMDN description: HAEMOGLOBIN CONTROLS
First on market country: Finland
Authorised representative: -
Last updated: 23.06.2026 11:37

Manufacturer products View details