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MyTest Infection Urinarie

IVD self-testing devicesIVDDOn the marketKitSelf testingSingle use

Manufacturer: PRIMA Lab SA
Manufacturer SRN: CH-MF-000034473
UDI-DI: D-300058LV
Basic UDI-DI: B-300058LV
Reference: 300058
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: France
Authorised representative: QbD RepS BV
Last updated: 25.07.2026 14:48

Manufacturer products Authorised representative products Authorised representative actors View details

Medi-Test Combi 2

Medi-Test URYXXON® Stick 10

IVD Class BIVDR 2017/746On the marketDirect markingMicrobial substancesNear-patient testingProfessional testingSingle use

Manufacturer: MACHEREY-NAGEL GmbH & Co. KG
Manufacturer SRN: DE-MF-000005636
UDI-DI: 04046681171727
Basic UDI-DI: 4046681151040VR
Reference: 93015.004
EMDN: W0101060201
EMDN description: URINE SINGLE TEST STRIPS (INCL. TABLETS)
First on market country: Denmark
Authorised representative: -
Last updated: 22.07.2026 22:58

Manufacturer products 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

D-CNMF000014455-BF-S095S4

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: D-CNMF000014455-BF-S095S4
Basic UDI-DI: B-CNMF000014455-BF-S095S4
Reference: BF-S095
EMDN: W0101060299
EMDN description: URINE TESTING - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:50

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-S094S2

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: D-CNMF000014455-BF-S094S2
Basic UDI-DI: B-CNMF000014455-BF-S094S2
Reference: BF-S094
EMDN: W0101060299
EMDN description: URINE TESTING - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:50

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-S093RY

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: D-CNMF000014455-BF-S093RY
Basic UDI-DI: B-CNMF000014455-BF-S093RY
Reference: BF-S093
EMDN: W0101060299
EMDN description: URINE TESTING - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:50

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-S092RW

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: D-CNMF000014455-BF-S092RW
Basic UDI-DI: B-CNMF000014455-BF-S092RW
Reference: BF-S092
EMDN: W0101060299
EMDN description: URINE TESTING - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:50

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-C093NG

BF C09

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagent

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-C093NG
Basic UDI-DI: B-CNMF000014455-BF-C093NG
Reference: BF-C093
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:44

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-C092NE

BF C09

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagent

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-C092NE
Basic UDI-DI: B-CNMF000014455-BF-C092NE
Reference: BF-C092
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:44

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-C091NC

BF C09

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagent

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-C091NC
Basic UDI-DI: B-CNMF000014455-BF-C091NC
Reference: BF-C091
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:44

Manufacturer products Authorised representative products Authorised representative actors View details

Urine Analysis Test (Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646URS001T9CW
Basic UDI-DI: B-697424646URS001T9CW
Reference: URS-1**1
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:16

Manufacturer products Authorised representative products Authorised representative actors View details

Urine Analysis Test Strip(Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646URS000T7CM
Basic UDI-DI: B-697424646URS000T7CM
Reference: URS-1111
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:16

Manufacturer products Authorised representative products Authorised representative actors View details

Urine strip test

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840309294
Basic UDI-DI: B-69743840309294
Reference: 3034502
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:11

Manufacturer products Authorised representative products Authorised representative actors View details

Alcohol Rapid Test(Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646ALC001DKNT
Basic UDI-DI: B-697424646ALC001DKNT
Reference: ALC-1011/ALC-1012/ALC-1014
EMDN: W0101060299
EMDN description: URINE TESTING - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:02

Manufacturer products Authorised representative products Authorised representative actors View details

Alcohol Rapid Test Kit(Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646ALC000DHNG
Basic UDI-DI: B-697424646ALC000DHNG
Reference: ALC-1011/ALC-1012/ALC-1014
EMDN: W0101060299
EMDN description: URINE TESTING - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:02

Manufacturer products Authorised representative products Authorised representative actors View details

Urine Adulteration(ADU) Test (Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646ADU001ERSE
Basic UDI-DI: B-697424646ADU001ERSE
Reference: ADU-1061
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:02

Manufacturer products Authorised representative products Authorised representative actors View details

Urine Adulteration Test (Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646ADU000EPS5
Basic UDI-DI: B-697424646ADU000EPS5
Reference: ADU-1061
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:02

Manufacturer products Authorised representative products Authorised representative actors View details

Urinalysis Reagent Strips

100 strips/bottle

IVD generalIVDDNo longer on the marketProfessional testingSingle use

Manufacturer: Nantong EgensBiotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000021561
UDI-DI: D-693757990URS25
Basic UDI-DI: B-693757990URS25
Reference: Urinalysis reagent strip
EMDN: W0101060299
EMDN description: URINE TESTING - OTHER
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 17.07.2026 03:49

Manufacturer products Authorised representative products Authorised representative actors View details