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Last updated

01.08.2026 12:34

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Device

2989310

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Active filter:EMDN:W020503

85 device results listed.

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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
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
GENEDIAN

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 productsAuthorised representative productsAuthorised representative actorsView details
EMAG® TIPS 1000µL

EMAG® TIPS 1000µL

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use
Manufacturer
bioMérieux SA
Manufacturer SRN
FR-MF-000004436
UDI-DI
03573026615253
Basic UDI-DI
357302BUDI000545TR
Reference
542568
EMDN
W02050385
EMDN description
NUCLEIC ACID TESTING INSTRUMENTS - RAPID AND POINT OF CARE TESTS - CONSUMABLES
First on market country
France
Authorised representative
-
Last updated
30.07.2026 20:55
Manufacturer productsView details
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
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06975514361050

-

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 productsAuthorised representative productsAuthorised representative actorsView details
06975514360077

-

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 productsAuthorised representative productsAuthorised representative actorsView details
06975514360053

-

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 productsAuthorised representative productsAuthorised representative actorsView details
06975514360060

-

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 productsAuthorised representative productsAuthorised representative actorsView details
06975514360046

-

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 productsAuthorised representative productsAuthorised representative actorsView details
06975514360084

-

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 productsAuthorised representative productsAuthorised representative actorsView details
06975514360022

-

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 productsAuthorised representative productsAuthorised representative actorsView details
06975514360039

-

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 productsAuthorised representative productsAuthorised representative actorsView details
Veros COVID-19

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 productsAuthorised representative productsAuthorised representative actorsView details
08809975890034

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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView details
Truelab® Quattro

603023001

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentNear-patient testingProfessional testing
Manufacturer
Molbio Diagnostics Limited
Manufacturer SRN
IN-MF-000028386
UDI-DI
08908007989965
Basic UDI-DI
8908007989965DD
Reference
603023001
EMDN
W02050399
EMDN description
NUCLEIC ACID TESTING INSTRUMENTS - RAPID AND POINT OF CARE TESTS - OTHER
First on market country
Germany
Authorised representative
QbD RepS BV
Last updated
03.07.2026 22:06
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Truelab® Duo

603022001

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentNear-patient testingProfessional testing
Manufacturer
Molbio Diagnostics Limited
Manufacturer SRN
IN-MF-000028386
UDI-DI
08908007989958
Basic UDI-DI
8908007989958DG
Reference
603022001
EMDN
W02050399
EMDN description
NUCLEIC ACID TESTING INSTRUMENTS - RAPID AND POINT OF CARE TESTS - OTHER
First on market country
Italy
Authorised representative
QbD RepS BV
Last updated
03.07.2026 22:06
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Truelab® Uno Dx

603021001

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentNear-patient testingProfessional testing
Manufacturer
Molbio Diagnostics Limited
Manufacturer SRN
IN-MF-000028386
UDI-DI
08908007989941
Basic UDI-DI
8908007989941CX
Reference
603021001
EMDN
W02050399
EMDN description
NUCLEIC ACID TESTING INSTRUMENTS - RAPID AND POINT OF CARE TESTS - OTHER
First on market country
Austria
Authorised representative
QbD RepS BV
Last updated
03.07.2026 22:06
Manufacturer productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView details