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TRUPCR® Viral RNA Extraction Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213930962
Basic UDI-DI: 8906213933B214VUT
Reference: 3B214V
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 16.07.2026 12:53

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® MTB/NTM DNA Extraction Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213930825
Basic UDI-DI: 8906213933B268EUW
Reference: 3B268E
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 16.07.2026 12:53

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TRUPCR® Bacterial/Fungal DNA Extraction Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213930795
Basic UDI-DI: 8906213933B345YV
Reference: 3B345
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 16.07.2026 12:53

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TRUPCR® Bacterial DNA Extraction Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213930764
Basic UDI-DI: 8906213933B371YW
Reference: 3B371
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 16.07.2026 12:53

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TRUPCR® MPL Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213930054
Basic UDI-DI: 89080153043B1305KX
Reference: 3B1305/C
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 16.07.2026 12:53

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06974756640862

Connection-cables

Class IMDR 2017/745On the marketActive deviceDirect markingMeasuring functionReusable

Manufacturer: Shenzhen Lontek Electronic Technology Co. Ltd.
Manufacturer SRN: CN-MF-000016279
UDI-DI: 06974756640862
Basic UDI-DI: 697475664G01SW
Reference: OEM-GO42A
EMDN: Z12040185
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - CONSUMABLES
First on market country: Italy
Authorised representative: Wellkang Ltd
Last updated: 16.07.2026 11:13

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DiaTrust

Microscope Slide

IVD Class AIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesMicrobial substancesProfessional testingSingle use

Manufacturer: DiaTrust Medical Co., Ltd
Manufacturer SRN: CN-MF-000009279
UDI-DI: 06974570460110
Basic UDI-DI: 6974570461010BC
Reference: B101-1001
EMDN: W0503900201
EMDN description: MICROSCOPE SLIDES
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 16.07.2026 11:11

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Automatic Blood Pressure Monitor

CH-S691L,CH-B607,CH-B606,CH-S692L,CH-S602,CH-W701L,CH-S693L,CH-B601L,CP-B01,CH-S603

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Cemho Medical Technology (Guangdong) Co., Ltd.
Manufacturer SRN: CN-MF-000040755
UDI-DI: 06973991533885
Basic UDI-DI: 6973991530518FG
Reference: CH-B607
EMDN: Z1203020302
EMDN description: NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS
First on market country: Belgium
Authorised representative: Wellkang Ltd
Last updated: 16.07.2026 11:09

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CITOTEST

Mailers

Class IMDR 2017/745On the market

Manufacturer: CITOTEST LABWARE MANUFACTURING CO.,LTD
Manufacturer SRN: CN-MF-000017214
UDI-DI: 06975085640523
Basic UDI-DI: 697079159MSA1001A00NAZ
Reference: 0500-1002
EMDN: W050299
EMDN description: DEVICES FOR SAMPLES TRANSPORT - OTHER
First on market country: Austria
Authorised representative: Wellkang Ltd
Last updated: 16.07.2026 11:03

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CITOSWAB

Nylon

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: CITOTEST LABWARE MANUFACTURING CO.,LTD
Manufacturer SRN: CN-MF-000017214
UDI-DI: 06942826221815
Basic UDI-DI: 697079159SWA1000B00RLK
Reference: 2123-1106
EMDN: A1101
EMDN description: SAMPLE COLLECTION NEUTRAL SWABS
First on market country: Austria
Authorised representative: Wellkang Ltd
Last updated: 16.07.2026 10:57

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CITOTEST

P.O.M

IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: CITOTEST LABWARE MANUFACTURING CO.,LTD
Manufacturer SRN: CN-MF-000017214
UDI-DI: 06942826221785
Basic UDI-DI: 697079159TECA000A00NF4
Reference: 0100-2156-16
EMDN: W05030501
EMDN description: INCLUSION DEVICES, CASSETTES
First on market country: Austria
Authorised representative: Wellkang Ltd
Last updated: 16.07.2026 10:57

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ORTHOVISIONS Wrist Electronic Blood Pressure Monitor

U62GH, U65H, U61GH, U60H, U61H, U62H, U63H, U67H, U68H, U60BH, U60K, U60B, U60CH, U60C, U60EH, U60E, U60I, U62I, U63I, U60GH, U60G

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Shenzhen Urion Technology Co., Ltd.
Manufacturer SRN: CN-MF-000018740
UDI-DI: 06953825911546
Basic UDI-DI: 69538259UWBP53
Reference: U61H
EMDN: Z1203020501
EMDN description: NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES
First on market country: Poland
Authorised representative: Wellkang Ltd
Last updated: 16.07.2026 10:50

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ORTHOVISIONS Infrared Thermometer

UFR102，UFR103，UFR116，UFR201，UFR203，UFR205

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Shenzhen Urion Technology Co., Ltd.
Manufacturer SRN: CN-MF-000018740
UDI-DI: 06953825911539
Basic UDI-DI: 69538259UIT9G
Reference: UFR201
EMDN: V0301010299
EMDN description: DIGITAL THERMOMETERS - OTHER
First on market country: Poland
Authorised representative: Wellkang Ltd
Last updated: 16.07.2026 10:50

Manufacturer products Authorised representative products Authorised representative actors View details

Upper Arm Electronic Blood Pressure Monitor

U90B, U90B Pro, U90B PIus, U90B Ultra, U90C, U90C Pro, U90C Plus, U90C Ultra

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Shenzhen Urion Technology Co., Ltd.
Manufacturer SRN: CN-MF-000018740
UDI-DI: 06953825911492
Basic UDI-DI: 69538259UABPZJ
Reference: U90B
EMDN: Z1203020501
EMDN description: NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 16.07.2026 10:50

Manufacturer products Authorised representative products Authorised representative actors View details

Wrist Watch Electronic Blood Pressure Monitor

U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Shenzhen Urion Technology Co., Ltd.
Manufacturer SRN: CN-MF-000018740
UDI-DI: 06953825911287
Basic UDI-DI: 69538259UWPM67
Reference: U16H
EMDN: Z1203020501
EMDN description: NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 16.07.2026 10:50

Manufacturer products Authorised representative products Authorised representative actors View details

06940131404985

HIV3-29204017000

IVD Class DIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use

Manufacturer: NewScen Coast Bio-Pharmaceutical Co.,Ltd.
Manufacturer SRN: CN-MF-000021934
UDI-DI: 06940131404985
Basic UDI-DI: 69401314HIV002CG
Reference: HIV3-29200111000
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Netherlands
Safety summary (SSCP/SSP): ZXKJ-CE-02-9 · Rev. Rev. A/4
Authorised representative: Wellkang Ltd
Last updated: 16.07.2026 10:38

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

20878799008156

Eye Spear

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: Surgistar Inc.
Manufacturer SRN: US-MF-000003747
UDI-DI: 20878799008156
Basic UDI-DI: 087879900PVASPEARRQ
Reference: 504090
EMDN: M0202030101
EMDN description: NON-WOVEN GAUZE PADS, WITHOUT X-RAY DETECTABLE THREAD, STERILE
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 16.07.2026 07:06

Manufacturer products Authorised representative products Authorised representative actors View details

00878799008077

Fluid Filter

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: Surgistar Inc.
Manufacturer SRN: US-MF-000003747
UDI-DI: 00878799008077
Basic UDI-DI: 087879900FLUIDFILTERPT
Reference: 501030
EMDN: A0499
EMDN description: SOLUTION FILTERS - OTHER
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 16.07.2026 07:02

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00878799007544

Capsule Polishing Cannulas

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Surgistar Inc.
Manufacturer SRN: US-MF-000003747
UDI-DI: 00878799007544
Basic UDI-DI: 087879900CapsulePolBK
Reference: 175005
EMDN: A010599
EMDN description: OPHTHALMOLOGY INJECTION NEEDLES AND KITS - OTHER
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 16.07.2026 07:02

Manufacturer products Authorised representative products Authorised representative actors View details

00878799008084

Eye Shield

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: Surgistar Inc.
Manufacturer SRN: US-MF-000003747
UDI-DI: 00878799008084
Basic UDI-DI: 087879900EYESHIELD6L
Reference: 501040
EMDN: Q029001
EMDN description: RIGID MONOCULAR MASKS
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 16.07.2026 07:02

Manufacturer products Authorised representative products Authorised representative actors View details