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06975102440150

V1-D/R-64JⅠ

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

Manufacturer: Jiangsu Qitian Gene biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000050877
UDI-DI: 06975102440150
Basic UDI-DI: 697510244LZD001FP
Reference: LZD001-32YⅠ
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 18:09

Manufacturer products Authorised representative products Authorised representative actors View details

06974987421360

Type A: 100 tests/kit Type B: 24 tests/kit Type B: 48 tests/kit Type B: 96 tests/kit Type C: 96 tests/kit Type D: 6×16 tests/kit

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Guangzhou KingCreate Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000032033
UDI-DI: 06974987421360
Basic UDI-DI: 697498742KS1480014Y
Reference: KS148-BYTQ-A100
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.07.2026 17:50

Manufacturer products Authorised representative products Authorised representative actors View details

Pathogen Nucleic Acid Extraction Kit

2×16 tests/kit

IVD Class AIVDR 2017/746On the marketDirect markingKitReagent

Manufacturer: Guangzhou KingCreate Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000032033
UDI-DI: 06974987420417
Basic UDI-DI: 697498742KS1260013U
Reference: KS126-TQ-2×16
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.07.2026 17:49

Manufacturer products Authorised representative products Authorised representative actors View details

06974969980588

Nucleic Acid Extraction Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Biobase Diagnostic Technology (Shandong) Co., Ltd.
Manufacturer SRN: CN-MF-000025964
UDI-DI: 06974969980588
Basic UDI-DI: 697496998ZD001YD
Reference: ZD001
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
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

Nucleic Acid Extraction Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shandong Bohong Gene Technology Co., Ltd.
Manufacturer SRN: CN-MF-000025971
UDI-DI: 06974901970103
Basic UDI-DI: 6974901BH002TY
Reference: BH002
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
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

06974898110995

Virus DNA/RNA Kit(Column)

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

Manufacturer: GENFINE BIOTECH(CHANGZHOU) CO.,LTD
Manufacturer SRN: CN-MF-000003399
UDI-DI: 06974898110995
Basic UDI-DI: 697489811000003Z8
Reference: D501:50preps/box
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
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

06974898110803

Virus DNA/RNA Kit(Magnetic Beads)

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

Manufacturer: GENFINE BIOTECH(CHANGZHOU) CO.,LTD
Manufacturer SRN: CN-MF-000003399
UDI-DI: 06974898110803
Basic UDI-DI: 697489811000002Z6
Reference: 502-Y: 10preps/box
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
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

06974898110612

DNA/RNA Extraction Kit(Column)

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

Manufacturer: GENFINE BIOTECH(CHANGZHOU) CO.,LTD
Manufacturer SRN: CN-MF-000003399
UDI-DI: 06974898110612
Basic UDI-DI: 697489811000004ZA
Reference: D801:50preps/box
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
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

06974898110001

DNA/RNA Extraction Kit(Magnetic Beads)

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

Manufacturer: GENFINE BIOTECH(CHANGZHOU) CO.,LTD
Manufacturer SRN: CN-MF-000003399
UDI-DI: 06974898110001
Basic UDI-DI: 697489811000001Z4
Reference: 101-Y: 10preps/box
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
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

Macro & Micro-Test Viral DNA/RNA Kit

Type Ⅰ: 50 tests/ kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849366525
Basic UDI-DI: 697484936W0105900101HP
Reference: HWTS-3017-50
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
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

06974795552010

10200602G

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: RocGene (Xuzhou) Technology Limited
Manufacturer SRN: CN-MF-000024511
UDI-DI: 06974795552010
Basic UDI-DI: 6974795552001GV
Reference: N/A
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 17:29

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic acid extraction and purification kit

96 tests/ kit

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

Manufacturer: Shanghai BioGerm Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000018164
UDI-DI: 06974677690250
Basic UDI-DI: 6974677690250J4
Reference: TQ-BG-008-96B-96
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: PureMDR GmbH
Last updated: 02.07.2026 17:09

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic acid extraction and purification kit

96 tests/ kit

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

Manufacturer: Shanghai BioGerm Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000018164
UDI-DI: 06974677690267
Basic UDI-DI: 6974677690267JM
Reference: TQ-BG-008-96D-96
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: PureMDR GmbH
Last updated: 02.07.2026 17:09

Manufacturer products Authorised representative products Authorised representative actors View details

Uni-medica

TypeB 100 tests/kit

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

Manufacturer: Shenzhen Uni-medica Technology Co., Ltd.
Manufacturer SRN: CN-MF-000022946
UDI-DI: 06974561520069
Basic UDI-DI: 697456152100tests/kit3M
Reference: 16.03.001.01
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 16:28

Manufacturer products Authorised representative products Authorised representative actors View details

Uni-medica

64T, 96T, 384T, 100T, 300T, 1000T, 4800T

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

Manufacturer: Shenzhen Uni-medica Technology Co., Ltd.
Manufacturer SRN: CN-MF-000022946
UDI-DI: 06974561520038
Basic UDI-DI: 69745615264TPF
Reference: 16.02.003.08
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 16:28

Manufacturer products Authorised representative products Authorised representative actors View details

06974541563420

ZK1000-1, ZK1500-1, ZK1000-5, ZK1500-2, ZK1500-3, ZK1500-4, ZK1500-5

IVD Class AIVDR 2017/746On the marketReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541563420
Basic UDI-DI: 697454156008L9
Reference: ZK1500-2
EMDN: W0105900103
EMDN description: SUPPLEMENTAL NA REAGENTS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 16:28

Manufacturer products Authorised representative products Authorised representative actors View details

HCY Nucleic Acid Extraction & Purification Kit

CY-M002-50, CY-M002-100, CY-M002-200, CY-M002-96, CY-M001-96, CY-M001-50, CY-M001-100, CY-M001-200

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Huachenyang (Shenzhen) Technology Co., Ltd.
Manufacturer SRN: CN-MF-000020236
UDI-DI: 06974488992086
Basic UDI-DI: 697448899CY-M0/0/8/2/8VFZ
Reference: CY-M002-50
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: France
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 16:19

Manufacturer products Authorised representative products Authorised representative actors View details

06974454728015

CWX112S

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

Manufacturer: Jiangsu CoWin Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008981
UDI-DI: 06974454728015
Basic UDI-DI: 697445472V26004X112SMX
Reference: CWX112S
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 16:10

Manufacturer products Authorised representative products Authorised representative actors View details

06974454727285

CWX101S/CWX101M

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

Manufacturer: Jiangsu CoWin Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008981
UDI-DI: 06974454727285
Basic UDI-DI: 697445472V21003X10146
Reference: CWX101S
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 16:10

Manufacturer products Authorised representative products Authorised representative actors View details

06974454727087

CWX102S/CWX103S/CWX103S-BR/CWX103S-ZY/CWX103S-SLD/CWX104S/CWX104S-BR/CWX104S-ZY/CWX104S-M

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

Manufacturer: Jiangsu CoWin Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008981
UDI-DI: 06974454727087
Basic UDI-DI: 697445472V21004X102-104VG
Reference: CWX102S
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 16:09

Manufacturer products Authorised representative products Authorised representative actors View details