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

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D-R0291229

R1：40ml×4，R2：20ml×2

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R0291229
Basic UDI-DI: B-R0291229
Reference: R02912
EMDN: W0101060106
EMDN description: UREA TEST STRIPS
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 21.07.2026 07:31

Manufacturer products Authorised representative products Authorised representative actors View details

Urine strips

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Kalians Corporation
Manufacturer SRN: EG-MF-000050142
UDI-DI: 62230182723286
Basic UDI-DI: B-62230182723286
Reference: D-795 001
EMDN: W0101060205
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 20.07.2026 04:47

Manufacturer products Authorised representative products Authorised representative actors View details

Urine strips Reagent strips for urinalysis for ten parameters

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Kalians Corporation
Manufacturer SRN: EG-MF-000050142
UDI-DI: 62230182723118
Basic UDI-DI: B-62230182723118
Reference: D-795 002
EMDN: W0101060205
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 20.07.2026 04:47

Manufacturer products Authorised representative products Authorised representative actors View details

06935784460709

BF S09

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: 06935784460709
Basic UDI-DI: B-06935784460709
Reference: BF-S091
EMDN: W0101060299
EMDN description: URINE TESTING - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 19.07.2026 07:57

Manufacturer products Authorised representative products Authorised representative actors View details

06935784450137

GM S02

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: 06935784450137
Basic UDI-DI: B-06935784450137
Reference: GLU-S53
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 19.07.2026 07:57

Manufacturer products Authorised representative products Authorised representative actors View details

06935784450120

GM S02

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: 06935784450120
Basic UDI-DI: B-06935784450120
Reference: GLU-S52
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 19.07.2026 07:57

Manufacturer products Authorised representative products Authorised representative actors View details

06935784450113

GM S02

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: 06935784450113
Basic UDI-DI: B-06935784450113
Reference: GLU-S51
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 19.07.2026 07:57

Manufacturer products Authorised representative products Authorised representative actors View details

06935784440503

GUK C01

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagent

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: 06935784440503
Basic UDI-DI: B-06935784440503
Reference: GUK-C011
EMDN: W010106040201
EMDN description: MULTIPLE PARAMETERS POC CONTROLS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 19.07.2026 07:57

Manufacturer products Authorised representative products Authorised representative actors View details

06935784440404

GUK S04

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: 06935784440404
Basic UDI-DI: B-06935784440404
Reference: GUK-S042
EMDN: W0101060109
EMDN description: MULTIPLE PARAMETER BLOOD TEST
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 19.07.2026 07:57

Manufacturer products Authorised representative products Authorised representative actors View details

06935784440305

GUK S03

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: 06935784440305
Basic UDI-DI: B-06935784440305
Reference: GUK-S032
EMDN: W0101060110
EMDN description: KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 19.07.2026 07:57

Manufacturer products Authorised representative products Authorised representative actors View details

06935784440206

GUK S02

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: 06935784440206
Basic UDI-DI: B-06935784440206
Reference: GUK-S022
EMDN: W01010699
EMDN description: CLIN. CHEM. RT & POC - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 19.07.2026 07:57

Manufacturer products Authorised representative products Authorised representative actors View details

Sinocare

Safe AQ

IVD Class CIVDR 2017/746On the marketDirect markingKitMicrobial substancesNear-patient testingProfessional testingReagentSelf testing

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175051120
Basic UDI-DI: 6934175001B0104NP
Reference: 12101271
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Italy
Safety summary (SSCP/SSP): MTN034-SR-301 · Rev. A.3
Authorised representative: SUNGO Europe B.V.
Last updated: 18.07.2026 15:09

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Sinocare

IVD Class CIVDR 2017/746On the marketDirect markingKitMicrobial substancesNear-patient testingProfessional testingReagentSelf testing

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175051700
Basic UDI-DI: 6934175001B0104NP
Reference: 12101043
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: -
Safety summary (SSCP/SSP): MTN034-SR-301 · Rev. A.3
Authorised representative: SUNGO Europe B.V.
Last updated: 18.07.2026 15:07

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

04712558769860

LS-05

IVD self-testing devicesIVDDOn the marketMicrobial substancesNear-patient testingProfessional testingSelf testingSingle use

Manufacturer: Visgeneer Inc.
Manufacturer SRN: TW-MF-000036547
UDI-DI: 04712558769860
Basic UDI-DI: B-04712558769860
Reference: 1320350
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 18.07.2026 04:39

Manufacturer products Authorised representative products Authorised representative actors View details

04712558769792

LS-03

IVD self-testing devicesIVDDOn the marketMicrobial substancesNear-patient testingProfessional testingSelf testingSingle use

Manufacturer: Visgeneer Inc.
Manufacturer SRN: TW-MF-000036547
UDI-DI: 04712558769792
Basic UDI-DI: B-04712558769792
Reference: 1320243
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 18.07.2026 04:39

Manufacturer products Authorised representative products Authorised representative actors View details

04712558769709

LS-04

IVD self-testing devicesIVDDOn the marketMicrobial substancesNear-patient testingProfessional testingSelf testingSingle use

Manufacturer: Visgeneer Inc.
Manufacturer SRN: TW-MF-000036547
UDI-DI: 04712558769709
Basic UDI-DI: B-04712558769709
Reference: 1320161
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 18.07.2026 04:39

Manufacturer products Authorised representative products Authorised representative actors View details

04712558769549

LS-03

IVD self-testing devicesIVDDOn the marketMicrobial substancesNear-patient testingProfessional testingSelf testingSingle use

Manufacturer: Visgeneer Inc.
Manufacturer SRN: TW-MF-000036547
UDI-DI: 04712558769549
Basic UDI-DI: B-04712558769549
Reference: 1320086
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 18.07.2026 04:39

Manufacturer products Authorised representative products Authorised representative actors View details

04712558769488

LS-04

IVD self-testing devicesIVDDOn the marketMicrobial substancesNear-patient testingProfessional testingSelf testingSingle use

Manufacturer: Visgeneer Inc.
Manufacturer SRN: TW-MF-000036547
UDI-DI: 04712558769488
Basic UDI-DI: B-04712558769488
Reference: 1320035
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 18.07.2026 04:39

Manufacturer products Authorised representative products Authorised representative actors View details

04712558769457

LS-04

IVD self-testing devicesIVDDOn the marketMicrobial substancesNear-patient testingProfessional testingSelf testingSingle use

Manufacturer: Visgeneer Inc.
Manufacturer SRN: TW-MF-000036547
UDI-DI: 04712558769457
Basic UDI-DI: B-04712558769457
Reference: 1320026
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 18.07.2026 04:39

Manufacturer products Authorised representative products Authorised representative actors View details

04712558769419

LS-03

IVD self-testing devicesIVDDOn the marketMicrobial substancesNear-patient testingProfessional testingSelf testingSingle use

Manufacturer: Visgeneer Inc.
Manufacturer SRN: TW-MF-000036547
UDI-DI: 04712558769419
Basic UDI-DI: B-04712558769419
Reference: 1320227
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 18.07.2026 04:39

Manufacturer products Authorised representative products Authorised representative actors View details