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EasyPure® Viral DNA/ RNA Kit

ER201

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

Manufacturer: TransGen Biotech Co., Ltd
Manufacturer SRN: CN-MF-000025790
UDI-DI: 06975422630026
Basic UDI-DI: 697542263ER201EB
Reference: ER201
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 18:56

Manufacturer products Authorised representative products Authorised representative actors View details

MagicPure® 96 Viral DNA/RNA Kit

EC301-96

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

Manufacturer: TransGen Biotech Co., Ltd
Manufacturer SRN: CN-MF-000025790
UDI-DI: 06975422630019
Basic UDI-DI: 697542263EC301-9694
Reference: EC301-96
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 18:56

Manufacturer products Authorised representative products Authorised representative actors View details

MagicPure® 32 Viral DNA/RNA Kit

EC301-32

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: TransGen Biotech Co., Ltd
Manufacturer SRN: CN-MF-000025790
UDI-DI: 06975422630002
Basic UDI-DI: 697542263EC301-328A
Reference: EC301-32
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 18:56

Manufacturer products Authorised representative products Authorised representative actors View details

06975330320033

TQ-XJ-D-032 ；TQ-XQ-R-032

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Hangzhou MiYin Biotechnology Co.,Ltd
Manufacturer SRN: CN-MF-000041649
UDI-DI: 06975330320033
Basic UDI-DI: 697533032MYNAEKRF
Reference: TQ-XJ-D-032
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 18:38

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic acid Extraction and Purification Kit

IVD Class AIVDR 2017/746On the marketKitReagentSingle use

Manufacturer: HANGZHOU ALLSHENG INSTRUMENTS CO.,LTD
Manufacturer SRN: CN-MF-000020502
UDI-DI: 06975141982291
Basic UDI-DI: 697514198RS002LH
Reference: -
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 18:16

Manufacturer products Authorised representative products Authorised representative actors View details

06975139678113

(12 tests), (24 tests), (48 tests)

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Beijing OriginPoly Bio-Tec Co., Ltd.
Manufacturer SRN: CN-MF-000043242
UDI-DI: 06975139678113
Basic UDI-DI: 697513967OPBT0083R
Reference: 12 tests/kit
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 18:15

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

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

06975102440396

RT-RAA Nucleic Acid Amplication Kit(Test Strip Method)

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

Manufacturer: Jiangsu Qitian Gene biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000050877
UDI-DI: 06975102440396
Basic UDI-DI: 697510244T00R01A7K
Reference: T00R01A
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: 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

06975102440389

RAA Nucleic Acid Amplication Kit(Test Strip Method)

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

Manufacturer: Jiangsu Qitian Gene biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000050877
UDI-DI: 06975102440389
Basic UDI-DI: 697510244T00001AY9
Reference: T00001A
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: 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

06975102440372

RT-RAA Nucleic Acid Amplication Kit(Fluorescent Method)

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

Manufacturer: Jiangsu Qitian Gene biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000050877
UDI-DI: 06975102440372
Basic UDI-DI: 697510244F00R01AY2
Reference: F00R01A
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: 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

06975102440365

RAA Nucleic Acid Amplication Kit(Fluorescent Method)

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

Manufacturer: Jiangsu Qitian Gene biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000050877
UDI-DI: 06975102440365
Basic UDI-DI: 697510244F00001AQT
Reference: F00001A
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: 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

06975102440358

RT-RAA Nucleic Acid Amplication Kit

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

Manufacturer: Jiangsu Qitian Gene biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000050877
UDI-DI: 06975102440358
Basic UDI-DI: 697510244B00R00AVT
Reference: B00R00A
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: 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

06975102440334

RAA Nucleic Acid Amplication Kit

IVD Class AIVDR 2017/746On the marketDirect markingKitReagentSingle use

Manufacturer: Jiangsu Qitian Gene biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000050877
UDI-DI: 06975102440334
Basic UDI-DI: 697510244B00000ANL
Reference: B00000A
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: 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

06975102440259

V2-D/R-64J

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

Manufacturer: Jiangsu Qitian Gene biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000050877
UDI-DI: 06975102440259
Basic UDI-DI: 697510244LZD002FR
Reference: LZD002-64Y
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