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02.08.2026 18:51

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681 device results listed.

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06973597100061

RTR-FS100

IVD Class AIVDR 2017/746Not intended for EU marketDirect markingInstrumentProfessional testing

Manufacturer: Xiamen United Medical Instruments Co., Ltd.
Manufacturer SRN: CN-MF-000028165
UDI-DI: 06973597100061
Basic UDI-DI: 697359710FS100HR
Reference: FS100
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 14:48

Manufacturer products Authorised representative products Authorised representative actors View details

06972426240244

TRACKER(H2)

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Guangzhou Richen-Frinse Optical &Electronic Co., Ltd.
Manufacturer SRN: CN-MF-000029615
UDI-DI: 06972426240244
Basic UDI-DI: 697242624CT05GX
Reference: CT05
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 12:54

Manufacturer products Authorised representative products Authorised representative actors View details

06972426240237

TRACKER(H2&CO2&CH4)

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Guangzhou Richen-Frinse Optical &Electronic Co., Ltd.
Manufacturer SRN: CN-MF-000029615
UDI-DI: 06972426240237
Basic UDI-DI: 697242624CT04GV
Reference: CT04
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 12:54

Manufacturer products Authorised representative products Authorised representative actors View details

06972426240305

HG-HpSA-2000

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Guangzhou Richen-Frinse Optical &Electronic Co., Ltd.
Manufacturer SRN: CN-MF-000029615
UDI-DI: 06972426240305
Basic UDI-DI: 697242624CG03ES
Reference: CG03
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 12:54

Manufacturer products Authorised representative products Authorised representative actors View details

06972426240275

13C/H2-BTF

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Guangzhou Richen-Frinse Optical &Electronic Co., Ltd.
Manufacturer SRN: CN-MF-000029615
UDI-DI: 06972426240275
Basic UDI-DI: 697242624CH02EV
Reference: CH02
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 12:54

Manufacturer products Authorised representative products Authorised representative actors View details

06972221451340

CBTSeq2 mini

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: CapitalBio Technology (Chengdu) Co., Ltd.
Manufacturer SRN: CN-MF-000027694
UDI-DI: 06972221451340
Basic UDI-DI: 697222145134FL
Reference: CBTSeq2 mini
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 12:36

Manufacturer products Authorised representative products Authorised representative actors View details

06972221451081

CBTSeq2 Pro

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: CapitalBio Technology (Chengdu) Co., Ltd.
Manufacturer SRN: CN-MF-000027694
UDI-DI: 06972221451081
Basic UDI-DI: 697222145108FK
Reference: CBTSeq2 Pro
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 12:36

Manufacturer products Authorised representative products Authorised representative actors View details

06972221450961

DxLab-32A

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: CapitalBio Technology (Chengdu) Co., Ltd.
Manufacturer SRN: CN-MF-000027694
UDI-DI: 06972221450961
Basic UDI-DI: 697222145096G5
Reference: DxLab-32A
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 12:36

Manufacturer products Authorised representative products Authorised representative actors View details

06972221450954

FS -3200

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: CapitalBio Technology (Chengdu) Co., Ltd.
Manufacturer SRN: CN-MF-000027694
UDI-DI: 06972221450954
Basic UDI-DI: 697222145095G3
Reference: FS-3200
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 12:36

Manufacturer products Authorised representative products Authorised representative actors View details

06972221450602

BioelectronSeq 4000

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: CapitalBio Technology (Chengdu) Co., Ltd.
Manufacturer SRN: CN-MF-000027694
UDI-DI: 06972221450602
Basic UDI-DI: 697222145060FG
Reference: BioelectronSeq 4000
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 12:36

Manufacturer products Authorised representative products Authorised representative actors View details

Chemistry and Immunoassay Integrated System

SAC-12, IOM-01, IOM-02, RWC-01, DQI-01, ST-04, ST-05, i 6000, C 1000, ISE

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Maccura Medical Instrument Co., Ltd.
Manufacturer SRN: CN-MF-000028087
UDI-DI: 06972168358580
Basic UDI-DI: 6972168356008B3
Reference: IM9501033
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Türkiye
Authorised representative: Humiss International B.V.
Last updated: 02.07.2026 12:35

Manufacturer products Authorised representative products Authorised representative actors View details

06971808258228

FF-S2400

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000033113
UDI-DI: 06971808258228
Basic UDI-DI: 697180825KL2400D5
Reference: FF-S2400
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Türkiye
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 12:17

Manufacturer products Authorised representative products Authorised representative actors View details

06971808256279

KL-200P

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000033113
UDI-DI: 06971808256279
Basic UDI-DI: 697180825KL200PEF
Reference: KL-200P
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Czechia
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 12:17

Manufacturer products Authorised representative products Authorised representative actors View details

06971808256262

TL-101

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000033113
UDI-DI: 06971808256262
Basic UDI-DI: 697180825KTL101LX
Reference: TL-101
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Czechia
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 12:17

Manufacturer products Authorised representative products Authorised representative actors View details

06971763229066

LS-2100

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Lansion Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000001086
UDI-DI: 06971763229066
Basic UDI-DI: 69717632247057002SK
Reference: L6-2100
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 12:15

Manufacturer products Authorised representative products Authorised representative actors View details

06971763229059

LS-1100

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Lansion Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000001086
UDI-DI: 06971763229059
Basic UDI-DI: 69717632247057001SH
Reference: L5-1100
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 12:15

Manufacturer products Authorised representative products Authorised representative actors View details

06971763225174

LS-10

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Lansion Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000001086
UDI-DI: 06971763225174
Basic UDI-DI: 69717632236785001UT
Reference: F1-10
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 12:15

Manufacturer products Authorised representative products Authorised representative actors View details

06971763225167

LS-30

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Lansion Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000001086
UDI-DI: 06971763225167
Basic UDI-DI: 69717632236785002UV
Reference: F3-30
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 12:15

Manufacturer products Authorised representative products Authorised representative actors View details

06971763224009

LS-4000

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Lansion Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000001086
UDI-DI: 06971763224009
Basic UDI-DI: 69717632248014001QZ
Reference: L4-4000
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 12:15

Manufacturer products Authorised representative products Authorised representative actors View details

CITOTEST

Cardboard

Class IMDR 2017/745On the market

Manufacturer: CITOTEST LABWARE MANUFACTURING CO.,LTD
Manufacturer SRN: CN-MF-000017214
UDI-DI: 06975085643814
Basic UDI-DI: 697079159SSDA200A00NUL
Reference: 2510-1401-16
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: Wellkang Ltd
Last updated: 02.07.2026 11:31

Manufacturer products Authorised representative products Authorised representative actors View details