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Active filter:Manufacturer SRN:CN-MF-000024105

8 device results listed.

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06975760470032

PCR (Polymerase Chain Reaction) Amplifying Apparatus

IVD Class AIVDR 2017/746On the marketInstrumentKit

Manufacturer: Suzhou Precigenome Ltd, Co;
Manufacturer SRN: CN-MF-000024105
UDI-DI: 06975760470032
Basic UDI-DI: 697576047CRS5RQ
Reference: L1699
EMDN: L1699
EMDN description: DIAGNOSTIC INSTRUMENTS, REUSABLE- OTHER
First on market country: Romania
Authorised representative: Lotus NL B.V.
Last updated: 27.09.2026 16:30

Manufacturer products Authorised representative products Authorised representative actors View details

06975760470049

Biochip Scanner

IVD Class AIVDR 2017/746On the marketInstrumentKit

Manufacturer: Suzhou Precigenome Ltd, Co;
Manufacturer SRN: CN-MF-000024105
UDI-DI: 06975760470049
Basic UDI-DI: 697576047CRS3RL
Reference: L1699
EMDN: L1699
EMDN description: DIAGNOSTIC INSTRUMENTS, REUSABLE- OTHER
First on market country: Romania
Authorised representative: Lotus NL B.V.
Last updated: 27.09.2026 16:30

Manufacturer products Authorised representative products Authorised representative actors View details

PIK3CA 11 Mutations Digital PCR Assay

24 Tests

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Suzhou Precigenome Ltd, Co;
Manufacturer SRN: CN-MF-000024105
UDI-DI: 06975760470186
Basic UDI-DI: B-06975760470186
Reference: 3.02.03.0005
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Spain
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 07.07.2026 00:11

Manufacturer products Authorised representative products Authorised representative actors View details

Human JAK2 Gene V617F Mutation Detection Kit (Digital PCR Method)

96 Tests

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Suzhou Precigenome Ltd, Co;
Manufacturer SRN: CN-MF-000024105
UDI-DI: 06975760470179
Basic UDI-DI: B-06975760470179
Reference: 3.02.03.0006
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Spain
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 07.07.2026 00:11

Manufacturer products Authorised representative products Authorised representative actors View details

BCR ABL p210/p190 digital PCR one-tube quant test

24 Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Suzhou Precigenome Ltd, Co;
Manufacturer SRN: CN-MF-000024105
UDI-DI: 06975760470162
Basic UDI-DI: B-06975760470162
Reference: 3.02.03.0001
EMDN: W01060208
EMDN description: T (9;22)
First on market country: Spain
Authorised representative: Lotus NL B.V.
Last updated: 07.07.2026 00:11

Manufacturer products Authorised representative products Authorised representative actors View details

Sepsis pathogenic microorganism detection kit (digital PCR)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Suzhou Precigenome Ltd, Co;
Manufacturer SRN: CN-MF-000024105
UDI-DI: 06975760470148
Basic UDI-DI: B-06975760470148
Reference: 3.02.03.0007
EMDN: W0104080601
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED BACTERIA SPP / SSPP
First on market country: Spain
Authorised representative: Lotus NL B.V.
Last updated: 07.07.2026 00:11

Manufacturer products Authorised representative products Authorised representative actors View details

06975760470124

Portable 16 sample PCR instrument

IVD Class AIVDR 2017/746On the marketInstrumentKit

Manufacturer: Suzhou Precigenome Ltd, Co;
Manufacturer SRN: CN-MF-000024105
UDI-DI: 06975760470124
Basic UDI-DI: 697576047CRS7RU
Reference: L1699
EMDN: L1699
EMDN description: DIAGNOSTIC INSTRUMENTS, REUSABLE- OTHER
First on market country: Romania
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 19:45

Manufacturer products Authorised representative products Authorised representative actors View details

06975760470131

RS3204 , RS3205, RS3206, RS3207

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Suzhou Precigenome Ltd, Co;
Manufacturer SRN: CN-MF-000024105
UDI-DI: 06975760470131
Basic UDI-DI: 697576047RS32S3
Reference: RS3204 , RS3205, RS3206, RS3207
EMDN: W02050180
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - HARDWARE ACCESSORIES
First on market country: Spain
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 02.07.2026 19:45

Manufacturer products Authorised representative products Authorised representative actors View details