Public EUDAMED Search

EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

Last updated

21.09.2026 01:52

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Device

3108040

Actor

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Certificate

3283

Active filter:Manufacturer SRN:CN-MF-000027212

99 device results listed.

Page 1 / 5

06975514360121

BFEX-16、BFEX-32、BFEX-96、BFEX-96E、BFEX-24E、BFEX-32E、BFEX-4E、BFEX-32P、BFEX-16E

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
Hangzhou Bigfish Bio-tech Co., Ltd.
Manufacturer SRN
CN-MF-000027212
UDI-DI
06975514360121
Basic UDI-DI
697551436BFEX001MK
Reference
BFEX-96E
EMDN
W02050106
EMDN description
DNA GENOMIC PREPARATION DEVICES
First on market country
Italy
Authorised representative
SUNGO Europe B.V.
Last updated
05.08.2026 18:48
06975514360114

BFEX-16、BFEX-32、BFEX-96、BFEX-96E、BFEX-24E、BFEX-32E、BFEX-4E、BFEX-32P、BFEX-16E

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
Hangzhou Bigfish Bio-tech Co., Ltd.
Manufacturer SRN
CN-MF-000027212
UDI-DI
06975514360114
Basic UDI-DI
697551436BFEX001MK
Reference
BFEX-96
EMDN
W02050106
EMDN description
DNA GENOMIC PREPARATION DEVICES
First on market country
Italy
Authorised representative
SUNGO Europe B.V.
Last updated
05.08.2026 16:29
06975514360107

BFEX-16、BFEX-32、BFEX-96、BFEX-96E、BFEX-24E、BFEX-32E、BFEX-4E、BFEX-32P、BFEX-16E

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
Hangzhou Bigfish Bio-tech Co., Ltd.
Manufacturer SRN
CN-MF-000027212
UDI-DI
06975514360107
Basic UDI-DI
697551436BFEX001MK
Reference
BFEX-32
EMDN
W02050106
EMDN description
DNA GENOMIC PREPARATION DEVICES
First on market country
Italy
Authorised representative
SUNGO Europe B.V.
Last updated
04.08.2026 22:23
06975514360091

BFEX-16、BFEX-32、BFEX-96、BFEX-96E、BFEX-24E、BFEX-32E、BFEX-4E、BFEX-32P、BFEX-16E

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
Hangzhou Bigfish Bio-tech Co., Ltd.
Manufacturer SRN
CN-MF-000027212
UDI-DI
06975514360091
Basic UDI-DI
697551436BFEX001MK
Reference
BFEX-16
EMDN
W02050106
EMDN description
DNA GENOMIC PREPARATION DEVICES
First on market country
Italy
Authorised representative
SUNGO Europe B.V.
Last updated
31.07.2026 21:44
06975514360015

BFQP-48、BFQP-96、BFQP-16

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
Hangzhou Bigfish Bio-tech Co., Ltd.
Manufacturer SRN
CN-MF-000027212
UDI-DI
06975514360015
Basic UDI-DI
697551436BFQP001PX
Reference
BFQP-4820
EMDN
W02050301
EMDN description
NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country
Italy
Authorised representative
SUNGO Europe B.V.
Last updated
31.07.2026 21:44
06975514361043

BFQP-48、BFQP-96、BFQP-16

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
Hangzhou Bigfish Bio-tech Co., Ltd.
Manufacturer SRN
CN-MF-000027212
UDI-DI
06975514361043
Basic UDI-DI
697551436BFQP001PX
Reference
BFQP-1620
EMDN
W02050301
EMDN description
NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country
Italy
Authorised representative
SUNGO Europe B.V.
Last updated
28.07.2026 06:56
IVD Class ANot specifiedOn the marketInstrumentProfessional testing
Manufacturer
Hangzhou Bigfish Bio-tech Co., Ltd.
Manufacturer SRN
CN-MF-000027212
UDI-DI
06975514361050
Basic UDI-DI
697551436BFQP001PX
Reference
BFQP-1650
EMDN
W02050301
EMDN description
NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country
-
Authorised representative
SUNGO Europe B.V.
Last updated
28.07.2026 06:46
06975514360954

1T、32T、96T、100T、256T

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use
Manufacturer
Hangzhou Bigfish Bio-tech Co., Ltd.
Manufacturer SRN
CN-MF-000027212
UDI-DI
06975514360954
Basic UDI-DI
697551436BFMP001NK
Reference
BFMP03R1
EMDN
W0104080699
EMDN description
NUCLEIC ACID IDENTIFICATION (BACTERIOLOGY) MANUAL / AUTOMATED - OTHER
First on market country
Italy
Authorised representative
SUNGO Europe B.V.
Last updated
22.07.2026 17:39
06975514360947

1T、32T、96T、100T、256T

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use
Manufacturer
Hangzhou Bigfish Bio-tech Co., Ltd.
Manufacturer SRN
CN-MF-000027212
UDI-DI
06975514360947
Basic UDI-DI
697551436BFMP001NK
Reference
BFMP01R1
EMDN
W0104080699
EMDN description
NUCLEIC ACID IDENTIFICATION (BACTERIOLOGY) MANUAL / AUTOMATED - OTHER
First on market country
Italy
Authorised representative
SUNGO Europe B.V.
Last updated
22.07.2026 17:37
06975514360930

1T、32T、96T、100T、256T

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use
Manufacturer
Hangzhou Bigfish Bio-tech Co., Ltd.
Manufacturer SRN
CN-MF-000027212
UDI-DI
06975514360930
Basic UDI-DI
697551436BFMP001NK
Reference
BFMP09R
EMDN
W0104080699
EMDN description
NUCLEIC ACID IDENTIFICATION (BACTERIOLOGY) MANUAL / AUTOMATED - OTHER
First on market country
Italy
Authorised representative
SUNGO Europe B.V.
Last updated
22.07.2026 17:34
06975514360923

1T、32T、96T、100T、256T

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use
Manufacturer
Hangzhou Bigfish Bio-tech Co., Ltd.
Manufacturer SRN
CN-MF-000027212
UDI-DI
06975514360923
Basic UDI-DI
697551436BFMP001NK
Reference
BFMP07R
EMDN
W0104080699
EMDN description
NUCLEIC ACID IDENTIFICATION (BACTERIOLOGY) MANUAL / AUTOMATED - OTHER
First on market country
Italy
Authorised representative
SUNGO Europe B.V.
Last updated
22.07.2026 17:32
06975514360916

1T、32T、96T、100T、256T

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use
Manufacturer
Hangzhou Bigfish Bio-tech Co., Ltd.
Manufacturer SRN
CN-MF-000027212
UDI-DI
06975514360916
Basic UDI-DI
697551436BFMP001NK
Reference
BFMP03R
EMDN
W0104080699
EMDN description
NUCLEIC ACID IDENTIFICATION (BACTERIOLOGY) MANUAL / AUTOMATED - OTHER
First on market country
Italy
Authorised representative
SUNGO Europe B.V.
Last updated
22.07.2026 17:31
06975514360909

1T、32T、96T、100T、256T

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use
Manufacturer
Hangzhou Bigfish Bio-tech Co., Ltd.
Manufacturer SRN
CN-MF-000027212
UDI-DI
06975514360909
Basic UDI-DI
697551436BFMP001NK
Reference
BFMP01R
EMDN
W0104080601
EMDN description
NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED BACTERIA SPP / SSPP
First on market country
Italy
Authorised representative
SUNGO Europe B.V.
Last updated
22.07.2026 17:29
06975514360817

FC-96B,FC-96BE,FC-96GE,FC-96D,FC-96G.FC-384G,FC-1536G,FC-48D,FC-48N,FC-48T

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
Hangzhou Bigfish Bio-tech Co., Ltd.
Manufacturer SRN
CN-MF-000027212
UDI-DI
06975514360817
Basic UDI-DI
697551436ThermalcyclerDH
Reference
FC-48N
EMDN
W02050116
EMDN description
NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country
Italy
Authorised representative
SUNGO Europe B.V.
Last updated
22.07.2026 17:28
IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
Hangzhou Bigfish Bio-tech Co., Ltd.
Manufacturer SRN
CN-MF-000027212
UDI-DI
06975514360824
Basic UDI-DI
697551436ThermalcyclerDH
Reference
FC-96B
EMDN
W02050116
EMDN description
NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country
-
Authorised representative
SUNGO Europe B.V.
Last updated
22.07.2026 17:28
IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
Hangzhou Bigfish Bio-tech Co., Ltd.
Manufacturer SRN
CN-MF-000027212
UDI-DI
06975514360831
Basic UDI-DI
697551436ThermalcyclerDH
Reference
FC-96GE
EMDN
W02050116
EMDN description
NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country
-
Authorised representative
SUNGO Europe B.V.
Last updated
22.07.2026 17:28
IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
Hangzhou Bigfish Bio-tech Co., Ltd.
Manufacturer SRN
CN-MF-000027212
UDI-DI
06975514360848
Basic UDI-DI
697551436ThermalcyclerDH
Reference
FC-96BE
EMDN
W02050116
EMDN description
NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country
-
Authorised representative
SUNGO Europe B.V.
Last updated
22.07.2026 17:28
IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
Hangzhou Bigfish Bio-tech Co., Ltd.
Manufacturer SRN
CN-MF-000027212
UDI-DI
06975514360855
Basic UDI-DI
697551436ThermalcyclerDH
Reference
FC-96D
EMDN
W02050116
EMDN description
NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country
-
Authorised representative
SUNGO Europe B.V.
Last updated
22.07.2026 17:28
IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
Hangzhou Bigfish Bio-tech Co., Ltd.
Manufacturer SRN
CN-MF-000027212
UDI-DI
06975514360862
Basic UDI-DI
697551436ThermalcyclerDH
Reference
FC-384G
EMDN
W02050116
EMDN description
NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country
-
Authorised representative
SUNGO Europe B.V.
Last updated
22.07.2026 17:28
IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
Hangzhou Bigfish Bio-tech Co., Ltd.
Manufacturer SRN
CN-MF-000027212
UDI-DI
06975514360879
Basic UDI-DI
697551436ThermalcyclerDH
Reference
FC-1536G
EMDN
W02050116
EMDN description
NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country
-
Authorised representative
SUNGO Europe B.V.
Last updated
22.07.2026 17:28