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269 device results listed.

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IDK® PMN-Elastase ELISA

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598000490
Basic UDI-DI: B-04050598000490
Reference: K 6830
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:39

Manufacturer products View details

IDK® PMN-Elastase ELISA

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598000506
Basic UDI-DI: B-04050598000506
Reference: K 6831
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:39

Manufacturer products View details

IDK® PMN-Elastase ELISA

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598000483
Basic UDI-DI: B-04050598000483
Reference: K 6841
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:39

Manufacturer products View details

DAO-REA (3H)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598000377
Basic UDI-DI: B-04050598000377
Reference: K 8220.2
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:39

Manufacturer products View details

Mycobacterium Multiplex-PCR Library Pre Kit

General

IVD Class AIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Shenzhen Health SwifTech Co., Ltd.
Manufacturer SRN: CN-MF-000044339
UDI-DI: 06977805760238
Basic UDI-DI: 697780576HSTAALIBMG6J
Reference: AA05-01-24S
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 22:59

Manufacturer products Authorised representative products Authorised representative actors View details

Mycobacterium Multiplex-PCR Library Pre Kit

Clinical

IVD Class AIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Shenzhen Health SwifTech Co., Ltd.
Manufacturer SRN: CN-MF-000044339
UDI-DI: 06977805760191
Basic UDI-DI: 697780576HSTAALIBMDK
Reference: AA05-01-24S
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 22:59

Manufacturer products Authorised representative products Authorised representative actors View details

06975769080010

1 test/bag, 20 tests/box

IVD Class AIVDR 2017/746On the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Hangzhou Proprium Biotech Co.Ltd
Manufacturer SRN: CN-MF-000035883
UDI-DI: 06975769080010
Basic UDI-DI: 697576908PWC3LP1DA
Reference: 20 tests/box
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Austria
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 19:45

Manufacturer products Authorised representative products Authorised representative actors View details

ADA 2

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Medicon Hellas SA
Manufacturer SRN: GR-MF-000013625
UDI-DI: 05204309171484
Basic UDI-DI: 5204309000004NJ
Reference: 1415-0902
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Greece
Authorised representative: -
Last updated: 02.07.2026 02:53

Manufacturer products View details

ADA

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Medicon Hellas SA
Manufacturer SRN: GR-MF-000013625
UDI-DI: 05204309152667
Basic UDI-DI: 5204309000003NG
Reference: 1419-0900
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Greece
Authorised representative: -
Last updated: 02.07.2026 02:53

Manufacturer products View details

ADA & ADA2

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Medicon Hellas SA
Manufacturer SRN: GR-MF-000013625
UDI-DI: 05204309132003
Basic UDI-DI: 5204309000063P2
Reference: 1418-0907
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Greece
Authorised representative: -
Last updated: 02.07.2026 02:53

Manufacturer products View details

IDK® DAO ELISA

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598013971
Basic UDI-DI: 4050598IALCIntolPY
Reference: Y8500
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 19:16

Manufacturer products View details

BIOSYNEX AMPLIQUICK Sample Treatment

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000014073
UDI-DI: 03532678593180
Basic UDI-DI: 353267F00128P8A
Reference: 3150063
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 12:26

Manufacturer products View details

BIOSYNEX AMPLIQUICK Lysis

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000014073
UDI-DI: 03532678592077
Basic UDI-DI: 353267F00061P82
Reference: 3150059_SEC01
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 12:26

Manufacturer products View details

08904226000023

MBK G6PD

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: ARKRAY Healthcare Pvt. Ltd.
Manufacturer SRN: IN-MF-000019015
UDI-DI: 08904226000023
Basic UDI-DI: 8904226096MB100YZ
Reference: 96MB100-10, 96MB100-10CC
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Austria
Authorised representative: Arazy Group GmbH
Last updated: 01.07.2026 09:20

Manufacturer products Authorised representative products Authorised representative actors View details

BIOSYNEX AMPLIQUICK Lysis

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000014073
UDI-DI: 03532678593074
Basic UDI-DI: 353267F00061P82
Reference: 3150059_SEC02
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: -
Authorised representative: -
Last updated: 28.06.2026 11:40

Manufacturer products View details

BIOSYNEX AMPLIQUICK Lysis

IVD Class AIVDR 2017/746No longer on the marketKitProfessional testingReagentSingle use

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000014073
UDI-DI: 03532678593081
Basic UDI-DI: 353267F00061P82
Reference: 3150059_BLK100
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: -
Authorised representative: -
Last updated: 28.06.2026 11:40

Manufacturer products View details

Biossays α-L-Fucosidase (CNPF)

α-L-Fucosidase (CNPF)

IVD Class CIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145561239
Basic UDI-DI: 69471455544WL
Reference: 130502013A
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:20

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays α-L-Fucosidase (CNPF)

α-L-Fucosidase (CNPF)

IVD Class CIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145561192
Basic UDI-DI: 69471455544WL
Reference: 130502013S
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:20

Manufacturer products Authorised representative products Authorised representative actors View details

06941967222743

IVD generalNot specifiedOn the market

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967222743
Basic UDI-DI: B-06941967222743
Reference: 01.09.03.04.EC.01
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 25.06.2026 20:48

Manufacturer products Authorised representative products Authorised representative actors View details

06941967208464

IVD generalNot specifiedOn the market

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967208464
Basic UDI-DI: B-06941967208464
Reference: 01.09.00.12.EC.01
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 25.06.2026 20:47

Manufacturer products Authorised representative products Authorised representative actors View details