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60 device results listed.

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THE EDGE

THE EDGE lactate control solution

IVD self-testing devicesIVDDOn the marketProfessional testingReagentSelf testing

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487610ALSZP
Basic UDI-DI: B-47136487610ALSZP
Reference: S5800024
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Poland
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

THE EDGE

THE EDGE Blood Lactate Monitoring System

IVD self-testing devicesIVDDOn the marketInstrumentKitMicrobial substancesProfessional testingReagentSelf testingSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487610A05K
Basic UDI-DI: B-47136487610A05K
Reference: S54108, S54153, S54154, S54155, S54156, S54157, S54158
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Poland
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

KETOSURE POC

KETOSURE POC base unit

IVD generalIVDDOn the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487609BU94
Basic UDI-DI: B-47136487609BU94
Reference: S5400044
EMDN: W0201069080
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

KETOSURE POC

KETOSURE POC Blood Ketone Test Strips

IVD generalIVDDOn the marketMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487609BKT3J
Basic UDI-DI: B-47136487609BKT3J
Reference: S5640894
EMDN: W0101060110
EMDN description: KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

KETOSURE POC

KETOSURE POC Ketone Control Solution

IVD generalIVDDOn the marketNear-patient testingProfessional testingReagent

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487609BKS3G
Basic UDI-DI: B-47136487609BKS3G
Reference: S5800358
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

KETOSURE POC

KetoSure POC Blood Ketone Monitoring System

IVD generalIVDDOn the marketInstrumentKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487609B06U
Basic UDI-DI: B-47136487609B06U
Reference: S11015
EMDN: W01010118
EMDN description: HYDROXYBUTYRATE DEHYDROGENASE
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

KET-1

KET-1 Blood Ketone Monitoring System

IVD self-testing devicesIVDDNo longer on the marketInstrumentKitMicrobial substancesProfessional testingReagentSelf testingSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487609A06R
Basic UDI-DI: B-47136487609A06R
Reference: S11004, S11008, S11009
EMDN: W0101060110
EMDN description: KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

Eclipse PLUS

Eclipse PLUS Urine Control Solution

IVD generalIVDDNo longer on the marketHuman tissuesNear-patient testingReagent

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487608BURS3Q
Basic UDI-DI: B-47136487608BURS3Q
Reference: S5800401 S5800402
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

Eclipse PLUS

Eclipse PLUS Microalbumin Reagent Kit

IVD generalIVDDNo longer on the marketAnimal tissuesNear-patient testingReagentSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487608BMATYU
Basic UDI-DI: B-47136487608BMATYU
Reference: S5641010 S5641011
EMDN: W0102160101
EMDN description: ALBUMIN INCL. UALBUMIN RT & POC
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

Eclipse PLUS

Eclipse PLUS Creatinine Reagent Kit

IVD generalIVDDNo longer on the marketAnimal tissuesNear-patient testingReagentSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487608BCRTYV
Basic UDI-DI: B-47136487608BCRTYV
Reference: S5641012 S5641013
EMDN: W0101060201
EMDN description: URINE SINGLE TEST STRIPS (INCL. TABLETS)
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

Eclipse PLUS

Eclipse PLUS ACR Reagent Kit

IVD generalIVDDNo longer on the marketAnimal tissuesNear-patient testingReagentSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487608BACRT2W
Basic UDI-DI: B-47136487608BACRT2W
Reference: S5641014 S5641015
EMDN: W0101060201
EMDN description: URINE SINGLE TEST STRIPS (INCL. TABLETS)
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

Eclipse PLUS

Eclipse PLUS Multi-Purpose Analyzer

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

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487608B06P
Basic UDI-DI: B-47136487608B06P
Reference: S35010
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

HemoSmart GOLD

HemoSmart GOLD hemoglobin test strips

IVD self-testing devicesIVDDOn the marketProfessional testingReagentSelf testingSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487606AHT2F
Basic UDI-DI: B-47136487606AHT2F
Reference: S5640254, S5640365, S5640733, S5640255, S5640682, S5640745
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Poland
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

Eclipse PLUS

Eclipse PLUS HbA1c Reagent Kit

IVD generalIVDDNo longer on the marketAnimal tissuesNear-patient testingReagentSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487608BA1CTWR
Basic UDI-DI: B-47136487608BA1CTWR
Reference: S5641008 S5641009
EMDN: W0102160102
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

HemoSmart GOLD

HemoSmart GOLD hemoglobin control solution

IVD self-testing devicesIVDDOn the marketProfessional testingReagentSelf testing

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487606AHS2D
Basic UDI-DI: B-47136487606AHS2D
Reference: S5800112
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Poland
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

HemoSmart GOLD

HemoSmart GOLD Hemoglobin Screening System

IVD self-testing devicesIVDDOn the marketInstrumentKitProfessional testingReagentSelf testingSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487606A06A
Basic UDI-DI: B-47136487606A06A
Reference: S25009, S25032, S25033
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

UASure II

UASure II Blood uric acid test strips

IVD self-testing devicesIVDDOn the marketProfessional testingReagentSelf testingSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487605AUT3F
Basic UDI-DI: B-47136487605AUT3F
Reference: S5640955, S5640956
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
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

UASure II

UASure II uric acid control solution

IVD self-testing devicesIVDDOn the marketProfessional testingReagentSelf testing

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487605AUS3D
Basic UDI-DI: B-47136487605AUS3D
Reference: S5800386
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

UASure II

UASure II/ UASure II Link Blood Uric Acid Monitoring System

IVD self-testing devicesIVDDOn the marketInstrumentKitProfessional testingReagentSelf testingSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487605A065
Basic UDI-DI: B-47136487605A065
Reference: S95050, S95056, S95055, S95057
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

UASure

UASure Uric Acid Test Strips

IVD self-testing devicesIVDDOn the marketReagentSelf testingSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487604A05Y
Basic UDI-DI: B-47136487604A05Y
Reference: S5640752
EMDN: W01010232
EMDN description: URIC ACID
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