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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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ENNOLIFE Clinical Chemistry Analyzer (Non-sterile)

HCA-TE-300

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect markingProfessional testing

Manufacturer: ProtectLife International Biomedical Inc.
Manufacturer SRN: TW-MF-000039217
UDI-DI: ++G322HCATE300
Basic UDI-DI: ++G322G322HCATE300MQQ8
Reference: HCA-TE-300
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Romania
Authorised representative: MedNet EC-REP GmbH
Last updated: 15.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

1100-1001

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

Manufacturer: Abaxis, Inc.
Manufacturer SRN: US-MF-000021651
UDI-DI: EABA11000000EI1
Basic UDI-DI: ++EABA11000000EI5D
Reference: 1100-0000EI
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Italy
Authorised representative: ABAXIS Europe GmbH
Last updated: 15.07.2026 18:55

Manufacturer products Authorised representative products Authorised representative actors View details

1100-1001

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

Manufacturer: Abaxis, Inc.
Manufacturer SRN: US-MF-000021651
UDI-DI: EABA11000000E1
Basic UDI-DI: ++EABA11000000E7F
Reference: 1100-0000E
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Germany
Authorised representative: ABAXIS Europe GmbH
Last updated: 15.07.2026 18:55

Manufacturer products Authorised representative products Authorised representative actors View details

1100-1001R

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

Manufacturer: Abaxis, Inc.
Manufacturer SRN: US-MF-000021651
UDI-DI: +EABA11000000ER1
Basic UDI-DI: ++EABA11000000ER5X
Reference: 1100-0000ER
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Germany
Authorised representative: ABAXIS Europe GmbH
Last updated: 15.07.2026 18:46

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00500-CL

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Gold Standard Diagnostics, LLC
Manufacturer SRN: US-MF-000027142
UDI-DI: B35000500CL0
Basic UDI-DI: ++B35000500CLJP
Reference: 00500-CL
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 15.07.2026 14:54

Manufacturer products Authorised representative products Authorised representative actors View details

00500

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Gold Standard Diagnostics, LLC
Manufacturer SRN: US-MF-000027142
UDI-DI: B350005000
Basic UDI-DI: ++B35000500BA
Reference: 00500
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 15.07.2026 14:54

Manufacturer products Authorised representative products Authorised representative actors View details

00350

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Gold Standard Diagnostics, LLC
Manufacturer SRN: US-MF-000027142
UDI-DI: B350003500
Basic UDI-DI: ++B35000350BF
Reference: 00350
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 15.07.2026 14:54

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ThunderBolt EIA (CLIA)

00300-CL

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Gold Standard Diagnostics, LLC
Manufacturer SRN: US-MF-000027142
UDI-DI: B35000300CL0
Basic UDI-DI: ++B35000300CLHZ
Reference: 00300-CL
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 15.07.2026 14:54

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ThunderBolt EIA

00300

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Gold Standard Diagnostics, LLC
Manufacturer SRN: US-MF-000027142
UDI-DI: B350003000
Basic UDI-DI: ++B35000300AY
Reference: 00300
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 15.07.2026 14:54

Manufacturer products Authorised representative products Authorised representative actors View details

Ledetect96

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: biomed Dr. Wieser GmbH
Manufacturer SRN: AT-MF-000028269
UDI-DI: 111938738460
Basic UDI-DI: PP13707READER74
Reference: Many
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Austria
Authorised representative: -
Last updated: 15.07.2026 14:43

Manufacturer products View details

uRI QUICK

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: STRUmed Solutions Private Limited
Manufacturer SRN: IN-MF-000023119
UDI-DI: D-uRIQUICKU8
Basic UDI-DI: B-uRIQUICKU8
Reference: uRI QUICK PRO UA14
EMDN: W02010701
EMDN description: URINALYSIS (UR) - LABORATORY ANALYSERS- INSTRUMENTS
First on market country: Greece
Authorised representative: Amstermed B.V.
Last updated: 15.07.2026 14:31

Manufacturer products Authorised representative products Authorised representative actors View details

iNSTA XPLOR® P

iNSTA XPLOR P

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: STRUmed Solutions Private Limited
Manufacturer SRN: IN-MF-000023119
UDI-DI: D-iNSTAXPLORPF8
Basic UDI-DI: B-iNSTAXPLORPF8
Reference: iNSTA XPLOR® P PA 001
EMDN: W0201020204
EMDN description: NEPHELOMETERS
First on market country: Greece
Authorised representative: Amstermed B.V.
Last updated: 15.07.2026 14:19

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BeneCheck Blood Glucose Monitoring System

VSG01D-2

IVD Annex II List BIVDDOn the marketInstrumentKitNear-patient testingProfessional testingSelf testing

Manufacturer: General Life Biotechnology Co., Ltd.
Manufacturer SRN: TW-MF-000027109
UDI-DI: D-VSG01D-2MH
Basic UDI-DI: B-VSG01D-2MH
Reference: VSG01D-2
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 15.07.2026 13:27

Manufacturer products Authorised representative products Authorised representative actors View details

BeneCheck Blood Glucose Monitoring System

VSG010-2

IVD Annex II List BIVDDOn the marketInstrumentKitNear-patient testingProfessional testingSelf testing

Manufacturer: General Life Biotechnology Co., Ltd.
Manufacturer SRN: TW-MF-000027109
UDI-DI: D-VSG010-2JJ
Basic UDI-DI: B-VSG010-2JJ
Reference: VSG010-2
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 15.07.2026 13:27

Manufacturer products Authorised representative products Authorised representative actors View details

LGLMV-02

IVD Annex II List BIVDDOn the marketInstrumentKitProfessional testingReagentSelf testing

Manufacturer: Tyson Bioresearch, Inc.
Manufacturer SRN: TW-MF-000027508
UDI-DI: D-T05H7990073KNX5
Basic UDI-DI: B-T05H7990073KNX5
Reference: LGLMV-02
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: France
Authorised representative: MDSS GmbH
Last updated: 15.07.2026 10:52

Manufacturer products Authorised representative products Authorised representative actors View details

Rossmax HS200

IVD Annex II List BIVDDOn the marketInstrumentKitProfessional testingReagentSelf testing

Manufacturer: Tyson Bioresearch, Inc.
Manufacturer SRN: TW-MF-000027508
UDI-DI: D-T05H1690071KNQQ
Basic UDI-DI: B-T05H1690071KNQQ
Reference: BGM_KIT_002_RM
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Belgium
Authorised representative: MDSS GmbH
Last updated: 15.07.2026 10:52

Manufacturer products Authorised representative products Authorised representative actors View details

Rossmax HS200

IVD self-testing devicesIVDDOn the marketInstrumentKitProfessional testingReagentSelf testing

Manufacturer: Tyson Bioresearch, Inc.
Manufacturer SRN: TW-MF-000027508
UDI-DI: D-T05H1690070KNQK
Basic UDI-DI: B-T05H1690070KNQK
Reference: BGM_KIT_004_RM
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Belgium
Authorised representative: MDSS GmbH
Last updated: 15.07.2026 10:52

Manufacturer products Authorised representative products Authorised representative actors View details

Rossmax HS200

IVD Annex II List BIVDDOn the marketInstrumentKitProfessional testingReagentSelf testing

Manufacturer: Tyson Bioresearch, Inc.
Manufacturer SRN: TW-MF-000027508
UDI-DI: D-T05H1690041KNQ3
Basic UDI-DI: B-T05H1690041KNQ3
Reference: BGM_KIT_001_RM
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Belgium
Authorised representative: MDSS GmbH
Last updated: 15.07.2026 10:52

Manufacturer products Authorised representative products Authorised representative actors View details

Rossmax HS200

IVD Annex II List BIVDDOn the marketInstrumentKitProfessional testingReagentSelf testing

Manufacturer: Tyson Bioresearch, Inc.
Manufacturer SRN: TW-MF-000027508
UDI-DI: D-T05H1690040KNPW
Basic UDI-DI: B-T05H1690040KNPW
Reference: BGM_KIT_002_RM
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Belgium
Authorised representative: MDSS GmbH
Last updated: 15.07.2026 10:52

Manufacturer products Authorised representative products Authorised representative actors View details

LGLMV-BT-01

IVD Annex II List BIVDDOn the marketInstrumentKitProfessional testingReagentSelf testing

Manufacturer: Tyson Bioresearch, Inc.
Manufacturer SRN: TW-MF-000027508
UDI-DI: D-T05G2J10011KNW9
Basic UDI-DI: B-T05G2J10011KNW9
Reference: LGLMV‐BT‐01
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: France
Authorised representative: MDSS GmbH
Last updated: 15.07.2026 10:52

Manufacturer products Authorised representative products Authorised representative actors View details