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Sinocare

IVD Class BIVDR 2017/746On the marketNear-patient testingProfessional testingReagent

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175026135
Basic UDI-DI: 6934175001B0520P9
Reference: 7D010
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 18:55

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Glucose Control Solution Level 2

IVD Class CIVDR 2017/746On the marketDirect markingNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175030453
Basic UDI-DI: 6934175001C0102NW
Reference: 1A004
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: -
Safety summary (SSCP/SSP): NPI052-SR-101 · Rev. A.2
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 18:55

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Cleaning liquid (Concentrated type)

Urinalysis Reagent

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794577269
Basic UDI-DI: 69257945W0101060299R0QZ
Reference: 3019971
EMDN: W0101060299
EMDN description: URINE TESTING - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 18:28

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Urine Sediment Analyzer Reagent Diluent

Urinalysis Reagent

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794576477
Basic UDI-DI: 69257945W010106020302R0FD
Reference: 3007269
EMDN: W010106020302
EMDN description: URINE SEDIMENT TEST KIT (AUTOMATED)
First on market country: Hungary
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 18:27

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ETALON Teszt

IVD Class CIVDR 2017/746On the marketReagentSelf testingSingle use

Manufacturer: 77 Elektronika Műszeripari Kft
Manufacturer SRN: HU-MF-000004266
UDI-DI: 05997345782881
Basic UDI-DI: 59973457ETC8X
Reference: ETN-9902
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Hungary
Safety summary (SSCP/SSP): SSP Dcont ETALON (D71) and variants, ETALON Teszt test strip v2 · Rev. 6
Authorised representative: -
Last updated: 31.07.2026 16:35

Manufacturer products Open in EUDAMED View details

FOB RAPID TEST CASSETTE (FECES), POSITIVE CONTROL SWAB INCLUDED

IVD Class BIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingSingle use

Manufacturer: VitroBioChem SRL
Manufacturer SRN: RO-MF-000010877
UDI-DI: 05944759080133
Basic UDI-DI: 5944759080VTFOB25FECPB62B
Reference: VT-FOB-25
EMDN: W0101060399
EMDN description: FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Romania
Authorised representative: -
Last updated: 31.07.2026 16:25

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Rotavirus Ag and Adenovirus Ag (Feces) COMBO Rapid Test Cassette Test rapid Rotavirus Ag si Adenovirus Ag (materii fecale) COMBO caseta

IVD Class BIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingSingle use

Manufacturer: VitroBioChem SRL
Manufacturer SRN: RO-MF-000010877
UDI-DI: 05944759080089
Basic UDI-DI: 5944759080VTRACG25FECB64H
Reference: VT-RAC-25
EMDN: W0101060399
EMDN description: FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Romania
Authorised representative: -
Last updated: 31.07.2026 16:25

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Giardia lamblia Ag (Feces)Rapid Test cassette Test rapid Giardia lamblia Ag (din materii fecale) caseta

IVD Class BIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingSingle use

Manufacturer: VitroBioChem SRL
Manufacturer SRN: RO-MF-000010877
UDI-DI: 05944759080065
Basic UDI-DI: 5944759080VTGIAG25FECB6XK
Reference: VT-GIA-25
EMDN: W0101060399
EMDN description: FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Romania
Authorised representative: -
Last updated: 31.07.2026 16:25

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Enterovirus Ag (feces) cassette Test rapid Enterovirus Ag (din materii fecale) caseta

IVD Class BIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingSingle use

Manufacturer: VitroBioChem SRL
Manufacturer SRN: RO-MF-000010877
UDI-DI: 05944759080034
Basic UDI-DI: 5944759080VTENTG25FECB6FW
Reference: VT-ENT-25
EMDN: W0101060399
EMDN description: FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Romania
Authorised representative: -
Last updated: 31.07.2026 16:25

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CYDXStrips Urine 2GP

Urine-10 - Urine-2GK - Urine-2GP - Urine-3

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Cypress Diagnostics
Manufacturer SRN: BE-MF-000000033
UDI-DI: 05404035100622
Basic UDI-DI: 54040351CYDXStripsWH
Reference: Urine-2GP
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:59

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CYDXStrips Urine 2GK

Urine-10 - Urine-2GK - Urine-2GP - Urine-3

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Cypress Diagnostics
Manufacturer SRN: BE-MF-000000033
UDI-DI: 05404035100615
Basic UDI-DI: 54040351CYDXStripsWH
Reference: Urine-2GK
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:50

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Urine 2AC

Urine-2AC

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Cypress Diagnostics
Manufacturer SRN: BE-MF-000000033
UDI-DI: 05404035100646
Basic UDI-DI: 54040351URINE-2AC38
Reference: Urine-2AC
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:46

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CYDXStrips Urine 10

Urine-10 - Urine-2GK - Urine-2GP - Urine-3

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Cypress Diagnostics
Manufacturer SRN: BE-MF-000000033
UDI-DI: 05404035100608
Basic UDI-DI: 54040351CYDXStripsWH
Reference: Urine-10
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:46

Manufacturer products View details

EASYMAX® Blood Glucose Test Strip

IVD Class CIVDR 2017/746On the marketDirect markingMicrobial substancesReagentSelf testingSingle use

Manufacturer: EPS Bio Technology Corp.
Manufacturer SRN: TW-MF-000028384
UDI-DI: 04713945680010
Basic UDI-DI: 471394568TP1NK
Reference: 680.01
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Greece
Safety summary (SSCP/SSP): I-T-T001033 · Rev. D
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 06:30

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

trister® Blood Glucose Test Strip