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A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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60 device results listed.

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Wellion AMADEUS

Wellion AMADEUS Blood Glucose Test Strips

IVD Annex II List BIVDDOn the marketMicrobial substancesProfessional testingReagentSelf testingSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487603C3TY5
Basic UDI-DI: B-47136487603C3TY5
Reference: S5641137, S5641138
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Austria
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:55

Manufacturer products Authorised representative products Authorised representative actors View details

Wellion AMADEUS

Wellion AMADEUS Control Solution

IVD Annex II List BIVDDOn the marketProfessional testingReagentSelf testing

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487603C3SY3
Basic UDI-DI: B-47136487603C3SY3
Reference: S5800475, S5800476, S5800477
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Austria
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:55

Manufacturer products Authorised representative products Authorised representative actors View details

Wellion AMADEUS

Wellion AMADEUS Set

IVD Annex II List BIVDDOn the marketInstrumentKitMicrobial substancesProfessional testingReagentSelf testingSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487603C367
Basic UDI-DI: B-47136487603C367
Reference: S70522, S70523
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Austria
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:55

Manufacturer products Authorised representative products Authorised representative actors View details

GlucoSure Advance II

GlucoSure Advance II Blood Glucose Test Strips

IVD Annex II List BIVDDOn the marketMicrobial substancesProfessional testingReagentSelf testingSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487603C1TXX
Basic UDI-DI: B-47136487603C1TXX
Reference: S5640626 S5640680 S5640679 S5641126
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Poland
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:55

Manufacturer products Authorised representative products Authorised representative actors View details

Contrex Plus 5

Contrex Plus 5 Glucose Control Solution

IVD Annex II List BIVDDOn the marketProfessional testingReagentSelf testing

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487603C1SXV
Basic UDI-DI: B-47136487603C1SXV
Reference: S5800301 S5800303 S5800459 S5800460 S5800461
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Poland
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:55

Manufacturer products Authorised representative products Authorised representative actors View details

GlucoSure Advance II

GlucoSure Advance II Blood Glucose Monitoring System

IVD Annex II List BIVDDOn the marketInstrumentKitMicrobial substancesProfessional testingReagentSelf testingSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487603C163
Basic UDI-DI: B-47136487603C163
Reference: S70335 S70350 S70512 S70513 S70514
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Poland
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:55

Manufacturer products Authorised representative products Authorised representative actors View details

GlucoSure POC Compact

GlucoSure POC Compact Blood Glucose Test strips

IVD generalIVDDNo longer on the marketMicrobial substancesNear-patient testingReagentSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487603B1TXS
Basic UDI-DI: B-47136487603B1TXS
Reference: S5641004 S5641005 S5641006 S5641007
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:55

Manufacturer products Authorised representative products Authorised representative actors View details

Contrex Plus 6

Contrex Plus 6 Glucose Control Solution

IVD generalIVDDNo longer on the marketNear-patient testingReagent

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487603B1SXQ
Basic UDI-DI: B-47136487603B1SXQ
Reference: S5800403 S5800404 S5800405
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:55

Manufacturer products Authorised representative products Authorised representative actors View details

GlucoSure POC Compact

GlucoSure POC Compact Blood Glucose Monitoring System

IVD generalIVDDNo longer on the marketInstrumentKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487603B15Y
Basic UDI-DI: B-47136487603B15Y
Reference: S70466, S70467
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:55

Manufacturer products Authorised representative products Authorised representative actors View details

GlucoSure POC

GlucoSure POC Blood Glucose and Ketone Monitoring System

IVD generalIVDDNo longer on the marketInstrumentKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487603B05W
Basic UDI-DI: B-47136487603B05W
Reference: S84512, S84511
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:55

Manufacturer products Authorised representative products Authorised representative actors View details

GlucoSure HT

GlucoSure HT blood glucose test strips

IVD Annex II List BIVDDOn the marketMicrobial substancesProfessional testingReagentSelf testingSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487602AT7U
Basic UDI-DI: B-47136487602AT7U
Reference: S5640693, S5640758, S5640657, S5640895, S5640918, S5640659
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Cyprus
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:55

Manufacturer products Authorised representative products Authorised representative actors View details

Contrex Plus 4

Contrex Plus 4 glucose control solution

IVD Annex II List BIVDDOn the marketProfessional testingReagentSelf testing

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487602AS7S
Basic UDI-DI: B-47136487602AS7S
Reference: S5800308, S5800153, S5800309, S5800154, S5800310, S5800155
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Cyprus
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:55

Manufacturer products Authorised representative products Authorised representative actors View details

GlucoSure HT Link

GlucoSure HT Link Blood Glucose Monitoring System

IVD Annex II List BIVDDNo longer on the marketInstrumentKitMicrobial substancesReagentSelf testingSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487602A15Q
Basic UDI-DI: B-47136487602A15Q
Reference: S70440, S70441, S70442
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:55

Manufacturer products Authorised representative products Authorised representative actors View details

GlucoSure HT

GlucoSure HT Blood Glucose Monitoring System

IVD Annex II List BIVDDOn the marketInstrumentKitMicrobial substancesReagentSelf testingSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487602A05N
Basic UDI-DI: B-47136487602A05N
Reference: S70385
EMDN: W01010213
EMDN description: GLUCOSE
First on market country: Cyprus
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:55

Manufacturer products Authorised representative products Authorised representative actors View details

GlucoSure Autocode

GlucoSure AutoCode blood glucose test strips

IVD Annex II List BIVDDOn the marketMicrobial substancesProfessional testingReagentSelf testingSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487601AT7P
Basic UDI-DI: B-47136487601AT7P
Reference: S5636096, S5640087, S5640249, S5640809, S5640259, S5636097, S5640088, S5640808, S5640751, S5640887, S5641016, S5641017
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:55

Manufacturer products Authorised representative products Authorised representative actors View details

Contrex Plus III

Contrex Plus III glucose control solution

IVD Annex II List BIVDDOn the marketProfessional testingReagentSelf testing

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487601AS7M
Basic UDI-DI: B-47136487601AS7M
Reference: S5800091
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:55

Manufacturer products Authorised representative products Authorised representative actors View details

GlucoSure Link

GlucoSure Link Blood Glucose test strips

IVD Annex II List BIVDDNo longer on the marketMicrobial substancesNear-patient testingReagentSelf testingSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487601A1TX7
Basic UDI-DI: B-47136487601A1TX7
Reference: S70453 S70454 S70455
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:55

Manufacturer products Authorised representative products Authorised representative actors View details

GlucoSure Link

GlucoSure Link Blood Glucose Monitoring System

IVD Annex II List BIVDDNo longer on the marketInstrumentKitMicrobial substancesReagentSelf testingSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487601A15K
Basic UDI-DI: B-47136487601A15K
Reference: S70453, S70454, S70455
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:55

Manufacturer products Authorised representative products Authorised representative actors View details

GlucoSure Autocode

GlucoSure Autocode Blood Glucose Monitoring System

IVD Annex II List BIVDDOn the marketInstrumentKitMicrobial substancesProfessional testingReagentSelf testingSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487601A05H
Basic UDI-DI: B-47136487601A05H
Reference: S70123, S70488
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:55

Manufacturer products Authorised representative products Authorised representative actors View details

Eclipse A1C

Eclipse A1C Hemoglobin A1c POC analyzer

IVD generalIVDDNo longer on the marketAnimal tissuesInstrumentKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487600B05F
Basic UDI-DI: B-47136487600B05F
Reference: S54133, S54144, S54145, S54119
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:55

Manufacturer products Authorised representative products Authorised representative actors View details