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EUDAMED Device Search

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

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01.08.2026 01:12

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70 device results listed.

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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

Manufacturer products Authorised representative products Authorised representative actors View details

iRapid 4

IVD Class AIVDR 2017/746Not intended for EU marketInstrumentProfessional testing

Manufacturer: Hangzhou DIAN Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000007252
UDI-DI: 06934244500139
Basic UDI-DI: 69342445IA002FK
Reference: P114-00004
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 18:56

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

-

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

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD Class ANot specifiedOn the marketInstrumentProfessional testing

Manufacturer: Hangzhou Bigfish Bio-tech Co., Ltd.
Manufacturer SRN: CN-MF-000027212
UDI-DI: 06975514360077
Basic UDI-DI: 697551436BFQP001PX
Reference: BFQP-482C
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: 22.07.2026 06:36

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD Class ANot specifiedOn the marketInstrumentProfessional testing

Manufacturer: Hangzhou Bigfish Bio-tech Co., Ltd.
Manufacturer SRN: CN-MF-000027212
UDI-DI: 06975514360053
Basic UDI-DI: 697551436BFQP001PX
Reference: BFQP-484C
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: 22.07.2026 06:36

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD Class ANot specifiedOn the marketInstrumentProfessional testing

Manufacturer: Hangzhou Bigfish Bio-tech Co., Ltd.
Manufacturer SRN: CN-MF-000027212
UDI-DI: 06975514360060
Basic UDI-DI: 697551436BFQP001PX
Reference: BFQP-485C
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: 22.07.2026 06:36

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD Class ANot specifiedOn the marketInstrumentProfessional testing

Manufacturer: Hangzhou Bigfish Bio-tech Co., Ltd.
Manufacturer SRN: CN-MF-000027212
UDI-DI: 06975514360046
Basic UDI-DI: 697551436BFQP001PX
Reference: BFQP-9650
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: 22.07.2026 06:36

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD Class ANot specifiedOn the marketInstrumentProfessional testing

Manufacturer: Hangzhou Bigfish Bio-tech Co., Ltd.
Manufacturer SRN: CN-MF-000027212
UDI-DI: 06975514360084
Basic UDI-DI: 697551436BFQP001PX
Reference: BFQP-965C
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: 22.07.2026 06:36

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD Class ANot specifiedOn the marketInstrumentProfessional testing

Manufacturer: Hangzhou Bigfish Bio-tech Co., Ltd.
Manufacturer SRN: CN-MF-000027212
UDI-DI: 06975514360022
Basic UDI-DI: 697551436BFQP001PX
Reference: BFQP-4840
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: 21.07.2026 22:52

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD Class ANot specifiedOn the marketInstrumentProfessional testing

Manufacturer: Hangzhou Bigfish Bio-tech Co., Ltd.
Manufacturer SRN: CN-MF-000027212
UDI-DI: 06975514360039
Basic UDI-DI: 697551436BFQP001PX
Reference: BFQP-4850
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: 21.07.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

CD0004-SP-107

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Sense Biodetection Limited
Manufacturer SRN: GB-MF-000022999
UDI-DI: 50608178000140
Basic UDI-DI: B-50608178000140
Reference: CD0004-SP-107
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 17.07.2026 02:23

Manufacturer products Authorised representative products Authorised representative actors View details

HysenDx 200

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hysen Biotech.Inc
Manufacturer SRN: KR-MF-000048224
UDI-DI: 08809975890034
Basic UDI-DI: 88099758902007000182
Reference: HysenDx 200
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002MFIA02F7JY

MFIA02-E

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002MFIA02F7JY
Basic UDI-DI: B-81649002MFIA02F7JY
Reference: MFIA02-E
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:05

Manufacturer products Authorised representative products Authorised representative actors View details

Rapi Q- Micro RT PCR System

IG2M5001

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Genes 2Me Private Limited
Manufacturer SRN: IN-MF-000035953
UDI-DI: 08906178200698
Basic UDI-DI: 890617820IG2M5001KQ
Reference: IG2M5001
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 21:53

Manufacturer products Authorised representative products Authorised representative actors View details

One PCR Ultra-Fast RT PCR System

IG2M5001UF

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentNear-patient testingProfessional testing

Manufacturer: Genes 2Me Private Limited
Manufacturer SRN: IN-MF-000035953
UDI-DI: 08906178200162
Basic UDI-DI: 890617820IG2M5001UF9L
Reference: IG2M5001UF
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 21:53

Manufacturer products Authorised representative products Authorised representative actors View details

G-seq500

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Geneus Technologies (Chengdu) Co., Ltd.
Manufacturer SRN: CN-MF-000050313
UDI-DI: 06979117020017
Basic UDI-DI: 697911702GS001EQ
Reference: G-seq500
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 03.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

Real-time PCR System

PCR Series

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Infitek Co., Ltd.
Manufacturer SRN: CN-MF-000048840
UDI-DI: 06978507780173
Basic UDI-DI: 697850778PCR10TL
Reference: IN0109
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Türkiye
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 23:37

Manufacturer products Authorised representative products Authorised representative actors View details

HTM-8T

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Suzhou Changhe Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000045901
UDI-DI: 06978380060003
Basic UDI-DI: 697838006CHMINIPCRYM
Reference: HTM-8T
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 23:29

Manufacturer products Authorised representative products Authorised representative actors View details

NATBox System

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Taizhou Cowingene Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000042619
UDI-DI: 06977537461755
Basic UDI-DI: 697753746CW07RE
Reference: CW07023Q
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 02.07.2026 22:41

Manufacturer products Authorised representative products Authorised representative actors View details