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Swab

Class IMDR 2017/745On the marketSingle use

Manufacturer: Biobase Diagnostic Technology (Shandong) Co., Ltd.
Manufacturer SRN: CN-MF-000025964
UDI-DI: 06974969980441
Basic UDI-DI: 697496998ZD003YH
Reference: ZD003
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 02.07.2026 17:48

Manufacturer products Authorised representative products Authorised representative actors View details

SALIVA COLLECTION KIT

MHM-A,MHM-B

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: MEDICO TECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000013067
UDI-DI: 06974931650310
Basic UDI-DI: 697493165SCKWC
Reference: MHM-A
EMDN: W05019002
EMDN description: SALIVA COLLECTION DEVICES
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 17:45

Manufacturer products Authorised representative products Authorised representative actors View details

06974931650143

MVTM-10A

IVD Class AIVDR 2017/746On the marketKitNear-patient testingProfessional testingSingle use

Manufacturer: MEDICO TECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000013067
UDI-DI: 06974931650143
Basic UDI-DI: 697493165DVSKTA
Reference: MVTM-5A(MH)
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Northern Ireland
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 17:45

Manufacturer products Authorised representative products Authorised representative actors View details

06974901970745

Swab

Class IMDR 2017/745On the marketSingle use

Manufacturer: Shandong Bohong Gene Technology Co., Ltd.
Manufacturer SRN: CN-MF-000025971
UDI-DI: 06974901970745
Basic UDI-DI: 6974901BH007UA
Reference: BH007
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 02.07.2026 17:42

Manufacturer products Authorised representative products Authorised representative actors View details

06974901970394

Disposable Virus Sampling Tube

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shandong Bohong Gene Technology Co., Ltd.
Manufacturer SRN: CN-MF-000025971
UDI-DI: 06974901970394
Basic UDI-DI: 6974901BH001TW
Reference: BH001
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 02.07.2026 17:42

Manufacturer products Authorised representative products Authorised representative actors View details

06974898111114

Specimen Collection Kit

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingSingle use

Manufacturer: GENFINE BIOTECH(CHANGZHOU) CO.,LTD
Manufacturer SRN: CN-MF-000003399
UDI-DI: 06974898111114
Basic UDI-DI: 697489811000007ZG
Reference: B:1preps/bag
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 02.07.2026 17:40

Manufacturer products Authorised representative products Authorised representative actors View details

06974884777478

Sample Collection Set

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Xi'an Tianlong Science and Technology Co., Ltd.
Manufacturer SRN: CN-MF-000001079
UDI-DI: 06974884777478
Basic UDI-DI: 697488477TLH007Z3
Reference: T500H
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 17:39

Manufacturer products Authorised representative products Authorised representative actors View details

Macro & Micro-Test Sample Collecting, Mailing & Shipping Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849366228
Basic UDI-DI: 697484936W05019099Y8
Reference: HWTS-3008-1
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 17:36

Manufacturer products Authorised representative products Authorised representative actors View details

CCTS

COYOTE® CCTS™ Respiratory Swab Specimen Collection Kit

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingSingle use

Manufacturer: Coyote Bioscience Co., Ltd.
Manufacturer SRN: CN-MF-000024155
UDI-DI: 06974767390176
Basic UDI-DI: 6974767396018003308Z
Reference: 6018003301-CE
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 17:26

Manufacturer products Authorised representative products Authorised representative actors View details

CCTS

COYOTE® CCTS™ Respiratory Swab Specimen Collection Kit

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingSingle use

Manufacturer: Coyote Bioscience Co., Ltd.
Manufacturer SRN: CN-MF-000024155
UDI-DI: 06974767390107
Basic UDI-DI: 6974767396018020208V
Reference: 6018020201-CE
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 17:26

Manufacturer products Authorised representative products Authorised representative actors View details

KEYU ParaSpin™ Intestinal Parasite Concentrator

KU-F05-IV

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735361825
Basic UDI-DI: 697473536KUC23PQ
Reference: KU-F05-IV
EMDN: W05019001
EMDN description: FAECES COLLECTION DEVICES
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

KEYU ParaFloat™ Intestinal Parasite Concentrator (Ova)

KU-F05-II

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735361818
Basic UDI-DI: 697473536KUC22PN
Reference: KU-F05-II
EMDN: W05019001
EMDN description: FAECES COLLECTION DEVICES
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

KEYU ParaSpin™ Intestinal Parasite Concentrator

KU-F05-I

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735361801
Basic UDI-DI: 697473536KUC21PL
Reference: KU-F05-I
EMDN: W05019001
EMDN description: FAECES COLLECTION DEVICES
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

KEYU Sample Collection Tube

Sample Collection Tube

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735361498
Basic UDI-DI: 697473536KUC15PR
Reference: KU-F03-I
EMDN: W05019001
EMDN description: FAECES COLLECTION DEVICES
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 17:20

Manufacturer products Authorised representative products Authorised representative actors View details

KEYU Sample Collection Container

Sample Collection Container

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735360194
Basic UDI-DI: 697473536KUC12PK
Reference: CUP-D
EMDN: W05019001
EMDN description: FAECES COLLECTION DEVICES
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 17:20

Manufacturer products Authorised representative products Authorised representative actors View details

KEYU Sample Collection Cup

Sample Collection Cup

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735360095
Basic UDI-DI: 697473536KUC07PS
Reference: KU-CUP-001
EMDN: W05019001
EMDN description: FAECES COLLECTION DEVICES
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 17:20

Manufacturer products Authorised representative products Authorised representative actors View details

Manual suction pump

Class IMDR 2017/745On the marketSingle use

Manufacturer: Dragon Medical Co.,Ltd
Manufacturer SRN: CN-MF-000011438
UDI-DI: 06974679019134
Basic UDI-DI: 697467901DWMSPUS
Reference: DW-SP
EMDN: W05019003
EMDN description: SPUTUM COLLECTION DEVICES
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 02.07.2026 17:09

Manufacturer products Authorised representative products Authorised representative actors View details

W05019099

60ml

IVD Class AIVDR 2017/746On the marketDirect markingSingle useSterile

Manufacturer: HBH BIOTECHNOLOGY LIMITED
Manufacturer SRN: CN-MF-000033712
UDI-DI: 06974594960092
Basic UDI-DI: 69745949660mlS8
Reference: 009
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Romania
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 16:40

Manufacturer products Authorised representative products Authorised representative actors View details

06974594960085

50ml

IVD Class AIVDR 2017/746On the marketDirect markingSingle useSterile

Manufacturer: HBH BIOTECHNOLOGY LIMITED
Manufacturer SRN: CN-MF-000033712
UDI-DI: 06974594960085
Basic UDI-DI: 69745949650mlRZ
Reference: 008
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Romania
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 16:40

Manufacturer products Authorised representative products Authorised representative actors View details

06974594960078

40ml

IVD Class AIVDR 2017/746On the marketDirect markingSingle useSterile

Manufacturer: HBH BIOTECHNOLOGY LIMITED
Manufacturer SRN: CN-MF-000033712
UDI-DI: 06974594960078
Basic UDI-DI: 69745949640mlRS
Reference: 007
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Romania
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 16:40

Manufacturer products Authorised representative products Authorised representative actors View details