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InfuseIT™ 1000ml Reusable Pressure Infusor

InfuseIT Pressure Infusor

Class IIaMDR 2017/745On the market

Manufacturer: Salter Labs, LLC
Manufacturer SRN: US-MF-000007934
UDI-DI: 10607411913393
Basic UDI-DI: 0607411TF20012a_PIB9F
Reference: ZIT-1020-5
EMDN: A0599
EMDN description: MECHANICAL INFUSION SYSTEMS, SINGLE-USE - OTHER
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 25.09.2026 03:33

Manufacturer products Authorised representative products Authorised representative actors View details

One Step hCG Urine Test

Cassette

IVD Class BIVDR 2017/746On the marketDirect markingKitNear-patient testingSelf testingSingle use

Manufacturer: Atlas Link Technology Co., Ltd.
Manufacturer SRN: CN-MF-000021058
UDI-DI: 06970725814944
Basic UDI-DI: 697072581B1HCG00N25S11CRP
Reference: C1103.02
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 25.09.2026 03:26

Manufacturer products Authorised representative products Authorised representative actors View details

08800037900838

SimplexTAS 101 ALT Reagent Cartridge

IVD generalIVDDOn the marketNear-patient testingProfessional testingReagentSingle use

Manufacturer: tascom co., ltd.
Manufacturer SRN: KR-MF-000019000
UDI-DI: 08800037900838
Basic UDI-DI: B-08800037900838
Reference: T0101085
EMDN: W01010103
EMDN description: ALANINE AMINO-TRANSFERASE
First on market country: Netherlands
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 25.09.2026 03:23

Manufacturer products Authorised representative products Authorised representative actors View details

08800037901262

SimplexTAS 101 AMY Reagent Cartridge

IVD generalIVDDOn the marketNear-patient testingProfessional testingReagentSingle use

Manufacturer: tascom co., ltd.
Manufacturer SRN: KR-MF-000019000
UDI-DI: 08800037901262
Basic UDI-DI: B-08800037901262
Reference: T0101025
EMDN: W01010107
EMDN description: AMYLASE - TOTAL
First on market country: Austria
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 25.09.2026 03:23

Manufacturer products Authorised representative products Authorised representative actors View details

08800037900845

SimplexTAS 101 AST Reagent Cartridge

IVD generalIVDDOn the marketNear-patient testingProfessional testingReagentSingle use

Manufacturer: tascom co., ltd.
Manufacturer SRN: KR-MF-000019000
UDI-DI: 08800037900845
Basic UDI-DI: B-08800037900845
Reference: T0101086
EMDN: W01010110
EMDN description: ASPARTATE AMINO-TRANSFERASE
First on market country: Austria
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 25.09.2026 03:23

Manufacturer products Authorised representative products Authorised representative actors View details

08800037900876

SimplexTAS 101 BUN Reagent Cartridge

IVD generalIVDDOn the marketNear-patient testingProfessional testingReagentSingle use

Manufacturer: tascom co., ltd.
Manufacturer SRN: KR-MF-000019000
UDI-DI: 08800037900876
Basic UDI-DI: B-08800037900876
Reference: T0101008
EMDN: W01010204
EMDN description: UREA/BLOOD UREA NITROGEN
First on market country: Austria
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 25.09.2026 03:23

Manufacturer products Authorised representative products Authorised representative actors View details

One Step hCG Urine Test

IVD Class BIVDR 2017/746On the marketDirect markingKitNear-patient testingSelf testingSingle use

Manufacturer: Atlas Link Technology Co., Ltd.
Manufacturer SRN: CN-MF-000021058
UDI-DI: 06970725815002
Basic UDI-DI: 697072581B1HCG00N25S11CRP
Reference: C1103.01
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 25.09.2026 03:23

Manufacturer products Authorised representative products Authorised representative actors View details

One Step hCG Urine Test

IVD Class BIVDR 2017/746On the marketDirect markingKitNear-patient testingSelf testingSingle use

Manufacturer: Atlas Link Technology Co., Ltd.
Manufacturer SRN: CN-MF-000021058
UDI-DI: 06970725814951
Basic UDI-DI: 697072581B1HCG00N25S11CRP
Reference: C1103.03
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 25.09.2026 03:23

Manufacturer products Authorised representative products Authorised representative actors View details

08800037900791

SimplexTAS 101 CK Reagent Cartridge

IVD generalIVDDOn the marketNear-patient testingProfessional testingReagentSingle use

Manufacturer: tascom co., ltd.
Manufacturer SRN: KR-MF-000019000
UDI-DI: 08800037900791
Basic UDI-DI: B-08800037900791
Reference: T0101036
EMDN: W01010113
EMDN description: CREATINE KINASE - TOTAL
First on market country: Austria
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 25.09.2026 03:23

Manufacturer products Authorised representative products Authorised representative actors View details

One Step hCG Urine Test

IVD Class BIVDR 2017/746On the marketDirect markingKitNear-patient testingSelf testingSingle use

Manufacturer: Atlas Link Technology Co., Ltd.
Manufacturer SRN: CN-MF-000021058
UDI-DI: 06970725815019
Basic UDI-DI: 697072581B1HCG00N25S11CRP
Reference: C1104.01
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 25.09.2026 03:23

Manufacturer products Authorised representative products Authorised representative actors View details

08800037901279

SimplexTAS 101 CK(W) Reagent Cartridge

IVD generalIVDDOn the marketNear-patient testingProfessional testingReagentSingle use

Manufacturer: tascom co., ltd.
Manufacturer SRN: KR-MF-000019000
UDI-DI: 08800037901279
Basic UDI-DI: B-08800037901279
Reference: T0101146
EMDN: W01010113
EMDN description: CREATINE KINASE - TOTAL
First on market country: Austria
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 25.09.2026 03:23

Manufacturer products Authorised representative products Authorised representative actors View details

One Step hCG Urine Test

IVD Class BIVDR 2017/746On the marketDirect markingKitNear-patient testingSelf testingSingle use

Manufacturer: Atlas Link Technology Co., Ltd.
Manufacturer SRN: CN-MF-000021058
UDI-DI: 06970725814968
Basic UDI-DI: 697072581B1HCG00N25S11CRP
Reference: C1104.02
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 25.09.2026 03:23

Manufacturer products Authorised representative products Authorised representative actors View details

08800037900869

SimplexTAS 101 CRE Reagent Cartridge

IVD generalIVDDOn the marketNear-patient testingProfessional testingReagentSingle use

Manufacturer: tascom co., ltd.
Manufacturer SRN: KR-MF-000019000
UDI-DI: 08800037900869
Basic UDI-DI: B-08800037900869
Reference: T0101005
EMDN: W01010207
EMDN description: CREATININE
First on market country: Austria
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 25.09.2026 03:23

Manufacturer products Authorised representative products Authorised representative actors View details

08800037900852

SimplexTAS 101 CRP Reagent Cartridge

IVD generalIVDDOn the marketNear-patient testingProfessional testingReagentSingle use

Manufacturer: tascom co., ltd.
Manufacturer SRN: KR-MF-000019000
UDI-DI: 08800037900852
Basic UDI-DI: B-08800037900852
Reference: T0101022
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Austria
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 25.09.2026 03:23

Manufacturer products Authorised representative products Authorised representative actors View details

One Step hCG Urine Test

IVD Class BIVDR 2017/746On the marketDirect markingKitNear-patient testingSelf testingSingle use

Manufacturer: Atlas Link Technology Co., Ltd.
Manufacturer SRN: CN-MF-000021058
UDI-DI: 06970725815026
Basic UDI-DI: 697072581B1HCG00N25S11CRP
Reference: C1105.01
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 25.09.2026 03:23

Manufacturer products Authorised representative products Authorised representative actors View details

08800037900951

SimplexTAS 101 GLU Reagent Cartridge

IVD generalIVDDOn the marketNear-patient testingProfessional testingReagentSingle use

Manufacturer: tascom co., ltd.
Manufacturer SRN: KR-MF-000019000
UDI-DI: 08800037900951
Basic UDI-DI: B-08800037900951
Reference: T0101001
EMDN: W01010213
EMDN description: GLUCOSE
First on market country: Austria
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 25.09.2026 03:23

Manufacturer products Authorised representative products Authorised representative actors View details

One Step hCG Urine Test

IVD Class BIVDR 2017/746On the marketDirect markingKitNear-patient testingSelf testingSingle use

Manufacturer: Atlas Link Technology Co., Ltd.
Manufacturer SRN: CN-MF-000021058
UDI-DI: 06970725815033
Basic UDI-DI: 697072581B1HCG00N25S11CRP
Reference: C1105.02
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 25.09.2026 03:23

Manufacturer products Authorised representative products Authorised representative actors View details

08800037900814

SimplexTAS 101 Hb Reagent Cartridge

IVD generalIVDDOn the marketNear-patient testingProfessional testingReagentSingle use

Manufacturer: tascom co., ltd.
Manufacturer SRN: KR-MF-000019000
UDI-DI: 08800037900814
Basic UDI-DI: B-08800037900814
Reference: T0101039
EMDN: W0103010601
EMDN description: HAEMOGLOBIN (HB)
First on market country: Austria
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 25.09.2026 03:23

Manufacturer products Authorised representative products Authorised representative actors View details

08800037900944

SimplexTAS 101 HbA1c Reagent Cartridge

IVD generalIVDDOn the marketNear-patient testingProfessional testingReagentSingle use

Manufacturer: tascom co., ltd.
Manufacturer SRN: KR-MF-000019000
UDI-DI: 08800037900944
Basic UDI-DI: B-08800037900944
Reference: T0101002
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Austria
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 25.09.2026 03:23

Manufacturer products Authorised representative products Authorised representative actors View details

08800037900883

SimplexTAS 101 HDL Reagent Cartridge

IVD generalIVDDOn the marketNear-patient testingProfessional testingReagentSingle use

Manufacturer: tascom co., ltd.
Manufacturer SRN: KR-MF-000019000
UDI-DI: 08800037900883
Basic UDI-DI: B-08800037900883
Reference: T0101017
EMDN: W01010215
EMDN description: HIGH DENSITY LIPOPROTEIN CHOLESTEROL
First on market country: Austria
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 25.09.2026 03:23

Manufacturer products Authorised representative products Authorised representative actors View details