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06975157920034

HB-2012A

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hybribio Medtech Device Co.,Ltd
Manufacturer SRN: CN-MF-000023113
UDI-DI: 06975157920034
Basic UDI-DI: 697515792HB2012ADL
Reference: HB-2012A
EMDN: W02050101
EMDN description: NUCLEIC ACID HYBRIDIZATION UNITS
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 18:17

Manufacturer products Authorised representative products Authorised representative actors View details

06975157920027

HHM-3

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hybribio Medtech Device Co.,Ltd
Manufacturer SRN: CN-MF-000023113
UDI-DI: 06975157920027
Basic UDI-DI: 697515792HHM3PP
Reference: HHM-3
EMDN: W02050101
EMDN description: NUCLEIC ACID HYBRIDIZATION UNITS
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 18:17

Manufacturer products Authorised representative products Authorised representative actors View details

06975157920010

HBQW-3200A

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hybribio Medtech Device Co.,Ltd
Manufacturer SRN: CN-MF-000023113
UDI-DI: 06975157920010
Basic UDI-DI: 697515792HBQW3200AMD
Reference: HBQW-3200A
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 18:17

Manufacturer products Authorised representative products Authorised representative actors View details

Reading Glasses

AUSTRIAS/CASTELLÓN/LETRAS/MILAN/TRIANA/MARSELLA/TOKIO/SENA/VOLGA

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Wenzhou Hengbo International Trade Co.,Ltd
Manufacturer SRN: CN-MF-000020548
UDI-DI: 06975142160018
Basic UDI-DI: 697514216RGP001H5
Reference: 06975142160018
EMDN: Q0210010102
EMDN description: MULTIFOCAL ORGANIC OPHTHALMIC LENSES (BIFOCAL, TRIFOCAL)
First on market country: Poland
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 18:16

Manufacturer products Authorised representative products Authorised representative actors View details

Bladder Scanner

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: SUZHOU PEAKSONIC MEDICAL TECHNOLOGY CO.,LTD.
Manufacturer SRN: CN-MF-000038246
UDI-DI: 06975124100780
Basic UDI-DI: 697512410M5X3
Reference: M5
EMDN: Z12080304
EMDN description: ULTRASONIC BLADDER VOLUME SCANNERS
First on market country: France
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 18:13

Manufacturer products Authorised representative products Authorised representative actors View details

Bladder Scanner

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: SUZHOU PEAKSONIC MEDICAL TECHNOLOGY CO.,LTD.
Manufacturer SRN: CN-MF-000038246
UDI-DI: 06975124100551
Basic UDI-DI: 697512410M4WZ
Reference: M4(without printer)
EMDN: Z12080304
EMDN description: ULTRASONIC BLADDER VOLUME SCANNERS
First on market country: France
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 18:13

Manufacturer products Authorised representative products Authorised representative actors View details

Bladder Scanner

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: SUZHOU PEAKSONIC MEDICAL TECHNOLOGY CO.,LTD.
Manufacturer SRN: CN-MF-000038246
UDI-DI: 06975124100438
Basic UDI-DI: 697512410M3WX
Reference: M3(without printer)
EMDN: Z12080304
EMDN description: ULTRASONIC BLADDER VOLUME SCANNERS
First on market country: France
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 18:13

Manufacturer products Authorised representative products Authorised representative actors View details

Bladder Scanner

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: SUZHOU PEAKSONIC MEDICAL TECHNOLOGY CO.,LTD.
Manufacturer SRN: CN-MF-000038246
UDI-DI: 06975124100216
Basic UDI-DI: 697512410M2WV
Reference: M2(without printer)
EMDN: Z12080304
EMDN description: ULTRASONIC BLADDER VOLUME SCANNERS
First on market country: France
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 18:13

Manufacturer products Authorised representative products Authorised representative actors View details

Bladder Scanner

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: SUZHOU PEAKSONIC MEDICAL TECHNOLOGY CO.,LTD.
Manufacturer SRN: CN-MF-000038246
UDI-DI: 06975124100056
Basic UDI-DI: 697512410M1WT
Reference: M1(without printer)
EMDN: Z12080304
EMDN description: ULTRASONIC BLADDER VOLUME SCANNERS
First on market country: France
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 18:13

Manufacturer products Authorised representative products Authorised representative actors View details

BeaverBeads™ Stool DNARNA Kit

70411

IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: BEAVER Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000020632
UDI-DI: 06975115120124
Basic UDI-DI: 69751151270411W8
Reference: 70411
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: France
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 18:09

Manufacturer products Authorised representative products Authorised representative actors View details

BeaverBeads™ Circulating DNA Kit

70404

IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: BEAVER Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000020632
UDI-DI: 06975115120117
Basic UDI-DI: 69751151270404WB
Reference: 70404
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: France
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 18:09

Manufacturer products Authorised representative products Authorised representative actors View details

BeaverBeads™ Saliva DNA Kit

70405

IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: BEAVER Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000020632
UDI-DI: 06975115120094
Basic UDI-DI: 69751151270405WD
Reference: 70405
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: France
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 18:09

Manufacturer products Authorised representative products Authorised representative actors View details

BeaverBeads™ Viral DNA RNA Kit

70406

IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: BEAVER Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000020632
UDI-DI: 06975115120087
Basic UDI-DI: 69751151270406WF
Reference: 70406
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: France
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 18:09

Manufacturer products Authorised representative products Authorised representative actors View details

BeaverBeads™ Blood DNA Kit

70423

IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: BEAVER Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000020632
UDI-DI: 06975115120070
Basic UDI-DI: 69751151270423WF
Reference: 70423
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: France
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 18:09

Manufacturer products Authorised representative products Authorised representative actors View details

Saliva Collector

43806

IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: BEAVER Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000020632
UDI-DI: 06975115120056
Basic UDI-DI: 69751151243806WP
Reference: 43806
EMDN: W05019002
EMDN description: SALIVA COLLECTION DEVICES
First on market country: France
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 18:09

Manufacturer products Authorised representative products Authorised representative actors View details

BEAVER™ Cell Free DNA Tubes

43803

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: BEAVER Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000020632
UDI-DI: 06975115120032
Basic UDI-DI: 69751151243803WH
Reference: 43803
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 18:09

Manufacturer products Authorised representative products Authorised representative actors View details

BeaverBeads™ Multi Sample RNA Kit

70418

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: BEAVER Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000020632
UDI-DI: 06975115120025
Basic UDI-DI: 69751151270418WN
Reference: 70418
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 18:09

Manufacturer products Authorised representative products Authorised representative actors View details

Sample Collection Kit

43903

IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: BEAVER Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000020632
UDI-DI: 06975115120018
Basic UDI-DI: 69751151243903WN
Reference: 43903
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: France
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 18:09

Manufacturer products Authorised representative products Authorised representative actors View details

Tencent AIMIS Digital Pathology Platform

PATH-PACS-01

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: Tencent Healthcare (Changsha) Co.,Ltd.
Manufacturer SRN: CN-MF-000019438
UDI-DI: 06975010050014
Basic UDI-DI: 697501005PATH01CG
Reference: 001
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Northern Ireland
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 17:54

Manufacturer products Authorised representative products Authorised representative actors View details

Tencent AIMIS Digital Pathology Platform

PATH-PACS-02

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: Tencent Healthcare (Changsha) Co.,Ltd.
Manufacturer SRN: CN-MF-000019438
UDI-DI: 06975010050021
Basic UDI-DI: 697501005PATH02CJ
Reference: 002
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Northern Ireland
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 17:54

Manufacturer products Authorised representative products Authorised representative actors View details