Public EUDAMED Search

EUDAMED Device Search

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

Last updated

03.08.2026 06:01

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Active filter:EMDN:W02010690

353 device results listed.

Page 12 / 18

06973316740240

Speedry Immun-chem

IVD Class AIVDR 2017/746Not intended for EU marketInstrumentNear-patient testingProfessional testing
Manufacturer
Diasia Biomedical Technology Co., Ltd.
Manufacturer SRN
CN-MF-000010281
UDI-DI
06973316740240
Basic UDI-DI
697331674DBIA00CW
Reference
A611011
EMDN
W0201069099
EMDN description
VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country
-
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
02.07.2026 14:30
06973316740202

Speedry ImmuFlu

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing
Manufacturer
Diasia Biomedical Technology Co., Ltd.
Manufacturer SRN
CN-MF-000010281
UDI-DI
06973316740202
Basic UDI-DI
697331674FIA02000HZ
Reference
A111011
EMDN
W0201069099
EMDN description
VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country
Austria
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
02.07.2026 14:30
IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN
CN-MF-000008763
UDI-DI
06973224897708
Basic UDI-DI
6973224890050A9
Reference
UC0172
EMDN
W0201069099
EMDN description
VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country
Netherlands
Authorised representative
Lotus NL B.V.
Last updated
02.07.2026 14:25
IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN
CN-MF-000008763
UDI-DI
06973224897678
Basic UDI-DI
6973224890049AQ
Reference
UC0171
EMDN
W0201069099
EMDN description
VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country
Netherlands
Authorised representative
Lotus NL B.V.
Last updated
02.07.2026 14:25
06973224897647

UC1-A UC1-B

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN
CN-MF-000008763
UDI-DI
06973224897647
Basic UDI-DI
6973224890048AN
Reference
UC0180
EMDN
W0201069099
EMDN description
VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country
Netherlands
Authorised representative
Lotus NL B.V.
Last updated
02.07.2026 14:25
LYSUN

GUKC-101

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN
CN-MF-000010254
UDI-DI
6971771203065
Basic UDI-DI
697177120GUKC101PX
Reference
GUKC-102
EMDN
W0201069099
EMDN description
VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country
Spain
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA
Last updated
02.07.2026 12:19
LYSUN

GUKC-102

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN
CN-MF-000010254
UDI-DI
6971771203058
Basic UDI-DI
697177120GUKC102PZ
Reference
GUKC-102
EMDN
W0201069099
EMDN description
VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country
Spain
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA
Last updated
02.07.2026 12:19
06971792050105

Portable Quantitative Immunoassay Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing
Manufacturer
Hangzhou Realy Tech Co.,Ltd.
Manufacturer SRN
CN-MF-000004716
UDI-DI
06971792050105
Basic UDI-DI
697179205AF3
Reference
RL-A2000
EMDN
W0201069099
EMDN description
VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country
Germany
Authorised representative
Medunion S.L.
Last updated
02.07.2026 12:17
IVD Class AIVDR 2017/746On the marketCompanion diagnosticsInstrumentNear-patient testingProfessional testing
Manufacturer
Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN
CN-MF-000010254
UDI-DI
06971771200200
Basic UDI-DI
69717712002007Q
Reference
LMF-101
EMDN
W0201069099
EMDN description
VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country
Netherlands
Authorised representative
Lotus NL B.V.
Last updated
02.07.2026 12:16
06934822535560

Compass2800-1, Compass2800-2

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing
Manufacturer
Jiangsu Konsung Bio-Medical Science And Technology Co.,Ltd.
Manufacturer SRN
CN-MF-000016839
UDI-DI
06934822535560
Basic UDI-DI
693482255660JJ
Reference
Compass2800-1
EMDN
W0201069099
EMDN description
VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country
Italy
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
02.07.2026 09:59
06934822535218

Compass3000-1, Compass3000-2

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testing
Manufacturer
Jiangsu Konsung Bio-Medical Science And Technology Co.,Ltd.
Manufacturer SRN
CN-MF-000016839
UDI-DI
06934822535218
Basic UDI-DI
693482255902JK
Reference
Compass3000-1
EMDN
W0201069099
EMDN description
VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country
Italy
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
02.07.2026 09:59
06934822535010

Compass2000-1, Compass2000-2

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing
Manufacturer
Jiangsu Konsung Bio-Medical Science And Technology Co.,Ltd.
Manufacturer SRN
CN-MF-000016839
UDI-DI
06934822535010
Basic UDI-DI
693482255600HY
Reference
Compass2000-1
EMDN
W0201069099
EMDN description
VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country
Italy
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
02.07.2026 09:59
IVD Class AIVDR 2017/746No longer on the marketInstrumentKitProfessional testing
Manufacturer
Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN
CN-MF-000012852
UDI-DI
06933260214051
Basic UDI-DI
69332602IT01000129W
Reference
BT0001001
EMDN
W0201069099
EMDN description
VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country
Germany
Authorised representative
Sungo Cert GmbH
Last updated
02.07.2026 09:53
IVD Class AIVDR 2017/746No longer on the marketInstrumentKitProfessional testing
Manufacturer
Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN
CN-MF-000012852
UDI-DI
06933260214020
Basic UDI-DI
69332602IT01000139Y
Reference
BT0001101
EMDN
W0201069099
EMDN description
VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country
Germany
Authorised representative
Sungo Cert GmbH
Last updated
02.07.2026 09:53
BIOTIME

FLI-600

IVD Class AIVDR 2017/746No longer on the marketInstrumentKitProfessional testing
Manufacturer
Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN
CN-MF-000012852
UDI-DI
06933260212361
Basic UDI-DI
69332602IT0100006A3
Reference
BT0301
EMDN
W0201069099
EMDN description
VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country
Poland
Authorised representative
Lotus NL B.V.
Last updated
02.07.2026 09:53
IVD Class AIVDR 2017/746No longer on the marketInstrumentKitProfessional testing
Manufacturer
Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN
CN-MF-000012852
UDI-DI
06933260212354
Basic UDI-DI
69332602IT0100008A7
Reference
BT0001501
EMDN
W0201069099
EMDN description
VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country
Germany
Authorised representative
Sungo Cert GmbH
Last updated
02.07.2026 09:53
BIOTIME

CLi-1600

IVD Class AIVDR 2017/746No longer on the marketInstrumentKitProfessional testing
Manufacturer
Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN
CN-MF-000012852
UDI-DI
06933260211388
Basic UDI-DI
69332602IT01000059Z
Reference
BT0000401
EMDN
W0201069099
EMDN description
VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country
Netherlands
Authorised representative
Sungo Cert GmbH
Last updated
02.07.2026 09:53
BIOTIME

ICE-100E

IVD Class AIVDR 2017/746No longer on the marketInstrumentKitProfessional testing
Manufacturer
Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN
CN-MF-000012852
UDI-DI
06933260211371
Basic UDI-DI
69332602IT01000019R
Reference
BTOHW
EMDN
W0201069099
EMDN description
VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country
Netherlands
Authorised representative
Sungo Cert GmbH
Last updated
02.07.2026 09:53
IVD Class AIVDR 2017/746No longer on the marketInstrumentKitProfessional testing
Manufacturer
Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN
CN-MF-000012852
UDI-DI
06933260209071
Basic UDI-DI
69332602IT0100014A2
Reference
BT0000201
EMDN
W0201069099
EMDN description
VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country
Netherlands
Authorised representative
Lotus NL B.V.
Last updated
02.07.2026 09:53
iProtin reader

BMREDP0101

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentNear-patient testingProfessional testing
Manufacturer
TAI-SAW TECHNOLOGY CO., LTD.
Manufacturer SRN
TW-MF-000041844
UDI-DI
04719892370073
Basic UDI-DI
471989237TO0001J9
Reference
BMREDP0101
EMDN
W0201069099
EMDN description
VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country
Czechia
Authorised representative
Emergo Europe B.V.
Last updated
02.07.2026 00:32