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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

spinit®

spinit® BC

IVD generalIVDDOn the marketNear-patient testingProfessional testingReagentSingle use

Manufacturer: biosurfit SA
Manufacturer SRN: PT-MF-000033920
UDI-DI: D-140300LX
Basic UDI-DI: B-140300LX
Reference: 140300
EMDN: W0103010604
EMDN description: WHITE BLOOD CELLS (WBC)
First on market country: Portugal
Authorised representative: -
Last updated: 11.07.2026 06:28

Manufacturer products View details

CBC-7 Hematology Control

CBC-7B

IVD generalIVDDOn the marketAnimal tissuesHuman tissues

Manufacturer: R&D Systems, Inc.
Manufacturer SRN: US-MF-000024485
UDI-DI: 10815762020343
Basic UDI-DI: B-10815762020343
Reference: 72001
EMDN: W0103010503
EMDN description: MULTILEVEL BLOOD CONTROLS
First on market country: France
Authorised representative: BIO-TECHNE SAS
Last updated: 11.07.2026 03:26

Manufacturer products Authorised representative products Authorised representative actors View details

CBC-3K Hematology Control

CBC-4K6

IVD generalIVDDOn the marketAnimal tissuesHuman tissues

Manufacturer: R&D Systems, Inc.
Manufacturer SRN: US-MF-000024485
UDI-DI: 10815762020251
Basic UDI-DI: B-10815762020251
Reference: 3K301
EMDN: W0103010501
EMDN description: NORMAL BLOOD CONTROLS
First on market country: France
Authorised representative: BIO-TECHNE SAS
Last updated: 11.07.2026 03:26

Manufacturer products Authorised representative products Authorised representative actors View details

CBC-3D Hematology Control

CBC-3D1

IVD generalIVDDOn the marketAnimal tissuesHuman tissues

Manufacturer: R&D Systems, Inc.
Manufacturer SRN: US-MF-000024485
UDI-DI: 10815762020091
Basic UDI-DI: B-10815762020091
Reference: 3D501
EMDN: W0103010503
EMDN description: MULTILEVEL BLOOD CONTROLS
First on market country: France
Authorised representative: BIO-TECHNE SAS
Last updated: 11.07.2026 03:26

Manufacturer products Authorised representative products Authorised representative actors 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

08809446081992

BHP-E02582

IVD generalIVDDOn the marketProfessional testingSingle use

Manufacturer: WELLS BIO, INC.
Manufacturer SRN: KR-MF-000031789
UDI-DI: 08809446081992
Basic UDI-DI: B-08809446081992
Reference: BHP-E02582
EMDN: W0103010201
EMDN description: HAEMOGLOBIN DETERMINATIONS (TOTAL HB)
First on market country: Italy
Authorised representative: MDSS GmbH
Last updated: 10.07.2026 14:10

Manufacturer products Authorised representative products Authorised representative actors View details

08809446080988

BGS-E02582

IVD generalIVDDOn the marketProfessional testingSingle use

Manufacturer: WELLS BIO, INC.
Manufacturer SRN: KR-MF-000031789
UDI-DI: 08809446080988
Basic UDI-DI: B-08809446080988
Reference: BGS-E02582
EMDN: W0103019001
EMDN description: CELLULAR ENZYME DETERMINATION REAGENTS (G-6-PDH, PYUVATE KINASE)
First on market country: Italy
Authorised representative: MDSS GmbH
Last updated: 10.07.2026 14:10

Manufacturer products Authorised representative products Authorised representative actors View details

08809446080971

BSG-E02582

IVD generalIVDDOn the marketProfessional testingSingle use

Manufacturer: WELLS BIO, INC.
Manufacturer SRN: KR-MF-000031789
UDI-DI: 08809446080971
Basic UDI-DI: B-08809446080971
Reference: BSG-E02582
EMDN: W0103019001
EMDN description: CELLULAR ENZYME DETERMINATION REAGENTS (G-6-PDH, PYUVATE KINASE)
First on market country: Italy
Authorised representative: MDSS GmbH
Last updated: 10.07.2026 14:09

Manufacturer products Authorised representative products Authorised representative actors View details

08809446080155

BSH-E02582

IVD generalIVDDOn the marketProfessional testingSingle use

Manufacturer: WELLS BIO, INC.
Manufacturer SRN: KR-MF-000031789
UDI-DI: 08809446080155
Basic UDI-DI: B-08809446080155
Reference: BSH-E02582
EMDN: W0103010201
EMDN description: HAEMOGLOBIN DETERMINATIONS (TOTAL HB)
First on market country: Italy
Authorised representative: MDSS GmbH
Last updated: 10.07.2026 14:09

Manufacturer products Authorised representative products Authorised representative actors View details

ADAMII™-CD3/CD4/CD8 Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317541020
Basic UDI-DI: B-08809317541020
Reference: CD348K-025
EMDN: W0103010199
EMDN description: REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 13:43

Manufacturer products Authorised representative products Authorised representative actors View details

ADAM-rWBC Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317541006
Basic UDI-DI: B-08809317541006
Reference: ADHK-050
EMDN: W0103010199
EMDN description: REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 13:43

Manufacturer products Authorised representative products Authorised representative actors View details

ADAMII-CD34 Kit

ADAMII™-CD34 Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317540634
Basic UDI-DI: B-08809317540634
Reference: CD34K-025
EMDN: W0103010199
EMDN description: REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 13:42

Manufacturer products Authorised representative products Authorised representative actors View details

08809317540276

ADAM-rWBC & ADAM-rWBC Kit

IVD generalIVDDOn the marketInstrumentKitProfessional testingReagent

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317540276
Basic UDI-DI: B-08809317540276
Reference: ADAM-rWBC & ADAM-rWBC Kit
EMDN: W0103010199
EMDN description: REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 13:42

Manufacturer products Authorised representative products Authorised representative actors View details

ADAM-rWBC Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317540269
Basic UDI-DI: B-08809317540269
Reference: AD1K-050
EMDN: W0103010199
EMDN description: REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 13:42

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

CERA-CHEK™ 3 in 1 GHL Hemoglobin Test Strip

M 400

IVD Annex II List BIVDDOn the marketNear-patient testingReagentSelf testingSingle use

Manufacturer: GC MEDIS Corp.
Manufacturer SRN: KR-MF-000012638
UDI-DI: 08800065140220
Basic UDI-DI: B-08800065140220
Reference: M400S11
EMDN: W0103010201
EMDN description: HAEMOGLOBIN DETERMINATIONS (TOTAL HB)
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 Test Strip

H 400

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

Manufacturer: GC MEDIS Corp.
Manufacturer SRN: KR-MF-000012638
UDI-DI: 08800065140022
Basic UDI-DI: B-08800065140022
Reference: B400S10
EMDN: W0103010201
EMDN description: HAEMOGLOBIN DETERMINATIONS (TOTAL HB)
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