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Sinocare

H101, H102

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

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175010721
Basic UDI-DI: 6934175001B0520P9
Reference: 7C005
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 19:04

Manufacturer products Authorised representative products Authorised representative actors View details

Sinocare

Level 1, Level 2

IVD Class BIVDR 2017/746Not intended for EU marketNear-patient testingProfessional testingReagent

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175009930
Basic UDI-DI: 6934175001C0501PG
Reference: REF 8C001, REF 8C002
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 19:04

Manufacturer products Authorised representative products Authorised representative actors View details

Sinocare

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

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175009947
Basic UDI-DI: 6934175001C0501PG
Reference: 8C002
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
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

Sinocare

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

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175010738
Basic UDI-DI: 6934175001B0520P9
Reference: 7C006
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

Sinocare

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

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175010745
Basic UDI-DI: 6934175001B0520P9
Reference: 7C007
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

Sinocare

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

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175010752
Basic UDI-DI: 6934175001B0520P9
Reference: 7C008
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

Sinocare

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

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175010769
Basic UDI-DI: 6934175001B0520P9
Reference: 7C009
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

Sinocare

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

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175010776
Basic UDI-DI: 6934175001B0520P9
Reference: 7C010
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

Sinocare

IVD Class BIVDR 2017/746Not intended for EU marketNear-patient testingProfessional testingReagent

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175026081
Basic UDI-DI: 6934175001B0520P9
Reference: REF 7C005, REF 7C006, REF 7C007, REF 7C008, REF 7C009, REF 7C010, REF 7D005, REF 7D006, REF 7D007, REF 7D008
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

Sinocare

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

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175026098
Basic UDI-DI: 6934175001B0520P9
Reference: 7D006
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

Sinocare

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

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175026104
Basic UDI-DI: 6934175001B0520P9
Reference: 7D007
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

Sinocare

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

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175026111
Basic UDI-DI: 6934175001B0520P9
Reference: 7D008
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

Sinocare

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

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175026128
Basic UDI-DI: 6934175001B0520P9
Reference: 7D009
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

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

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

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products View details

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

Manufacturer products View details