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26935784400037

A1C EZ 2.0

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

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: 26935784400037
Basic UDI-DI: B-26935784400037
Reference: A1C-S22
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 15:44

Manufacturer products Authorised representative products Authorised representative actors View details

Test-Reagent for 5-hydroxyindoleacetic acid

0.5ml x100 pieces

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Wuhan Chenkang Science&Technology Co., LTD
Manufacturer SRN: CN-MF-000031528
UDI-DI: 26935734968884
Basic UDI-DI: B-26935734968884
Reference: C015
EMDN: W0101060299
EMDN description: URINE TESTING - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 11.07.2026 15:43

Manufacturer products Authorised representative products Authorised representative actors View details

Uriflet S 9UB

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-23905GG
Basic UDI-DI: B-23905GG
Reference: 23905
EMDN: W0101060205
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 15:38

Manufacturer products Authorised representative products Authorised representative actors View details

AUTION Sticks 10EA

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-20286FJ
Basic UDI-DI: B-20286FJ
Reference: 20286
EMDN: W0101060205
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 14:28

Manufacturer products Authorised representative products Authorised representative actors View details

D-1857B

Carbon Dioxide Kit (PEPC Method)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-1857B
Basic UDI-DI: B-1857B
Reference: /
EMDN: W0101060601
EMDN description: CARBON DIOXIDE - ELECTRODES (BG)
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 10:28

Manufacturer products Authorised representative products Authorised representative actors View details

16935784450073

GM S01

IVD self-testing devicesIVDDOn the marketKitProfessional testingReagentSelf testingSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: 16935784450073
Basic UDI-DI: B-16935784450073
Reference: GLU-S42
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

16935784420052

GLU-A1C S06

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

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: 16935784420052
Basic UDI-DI: B-16935784420052
Reference: GLU-S32
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

16935784411173

A1C-EXP S01

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: 16935784411173
Basic UDI-DI: B-16935784411173
Reference: A1C-S42
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

16935784400078

GLU-A1C S05

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

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: 16935784400078
Basic UDI-DI: B-16935784400078
Reference: GCA-S32
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 08:57

Manufacturer products Authorised representative products Authorised representative actors View details

16935784400061

A1C-PRO S01

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: 16935784400061
Basic UDI-DI: B-16935784400061
Reference: A1C-S32
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 08:57

Manufacturer products Authorised representative products Authorised representative actors View details

16935784400054

GLU-A1C S04

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

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: 16935784400054
Basic UDI-DI: B-16935784400054
Reference: GLU-S22
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 08:57

Manufacturer products Authorised representative products Authorised representative actors View details

16935784400030

A1C EZ 2.0

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

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: 16935784400030
Basic UDI-DI: B-16935784400030
Reference: A1C-S22
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 08:57

Manufacturer products Authorised representative products Authorised representative actors View details

Test-Reagent for 5-hydroxyindoleacetic acid

0.5ml x 10pieces

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Wuhan Chenkang Science&Technology Co., LTD
Manufacturer SRN: CN-MF-000031528
UDI-DI: 16935734968887
Basic UDI-DI: B-16935734968887
Reference: C015
EMDN: W0101060299
EMDN description: URINE TESTING - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 11.07.2026 08:57

Manufacturer products Authorised representative products Authorised representative actors View details

16935784400047

GLU-A1C S03

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

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: 16935784400047
Basic UDI-DI: B-16935784400047
Reference: GCA-S22
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 08:57

Manufacturer products Authorised representative products Authorised representative actors View details

Urinalysis Strips

100 strips/bottle×10 + 1 CPU card (FUS-10Ⅱ)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 16925794573664
Basic UDI-DI: B-16925794573664
Reference: 3008626
EMDN: W0101060205
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 11.07.2026 08:55

Manufacturer products Authorised representative products Authorised representative actors View details

Urinalysis Strips

100 strips/bottle×10 + 1 CPU card (FUS-14CaⅡ)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 16925794514865
Basic UDI-DI: B-16925794514865
Reference: 3008666
EMDN: W0101060205
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 11.07.2026 08:55

Manufacturer products Authorised representative products Authorised representative actors View details

Urinalysis Strips

100 strips/bottle×10 + 1 CPU card (FUS-13CrⅡ)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 16925794514858
Basic UDI-DI: B-16925794514858
Reference: 3008658
EMDN: W0101060205
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 11.07.2026 08:55

Manufacturer products Authorised representative products Authorised representative actors View details

Urinalysis Strips

100 strips/bottle×10 + 1 CPU card (FUS-12MAⅡ)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 16925794514841
Basic UDI-DI: B-16925794514841
Reference: 3008650
EMDN: W0101060205
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 11.07.2026 08:55

Manufacturer products Authorised representative products Authorised representative actors View details

Urinalysis Strips

100 strips/bottle×10 + 1 CPU card (FUS-11MAⅡ)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 16925794514834
Basic UDI-DI: B-16925794514834
Reference: 3008642
EMDN: W0101060205
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 11.07.2026 08:55

Manufacturer products Authorised representative products Authorised representative actors View details

Urinalysis Strips

100 strips/bottle×10 + 1 CPU card (FUS-11Ⅱ)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 16925794514827
Basic UDI-DI: B-16925794514827
Reference: 3008634
EMDN: W0101060205
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 11.07.2026 08:55

Manufacturer products Authorised representative products Authorised representative actors View details