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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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Ethyl Glucuronide III Enzyme Immunoassay

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use

Manufacturer: Lin-Zhi International, Inc.
Manufacturer SRN: US-MF-000003373
UDI-DI: 00850624008568
Basic UDI-DI: 0850624008EIAEtG30225
Reference: 09976523190
EMDN: W0102090220
EMDN description: ETHYL GLUCURONIDE
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 16.07.2026 06:33

Manufacturer products Authorised representative products Authorised representative actors View details

Ethyl Glucuronide 200 Control Set

Ethyl Glucuronide Calibrators and Controls

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesProfessional testing

Manufacturer: Lin-Zhi International, Inc.
Manufacturer SRN: US-MF-000003373
UDI-DI: 00850624008575
Basic UDI-DI: 0850624008CCEtG302HJ
Reference: 09976507190
EMDN: W0102152009
EMDN description: CONTROLS FOR NARCOTICS / TOXICOLOGY
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 16.07.2026 06:33

Manufacturer products Authorised representative products Authorised representative actors View details

Buprenorphine 5 Qualitative Calibrator Set

Buprenorphine Calibrators and Controls

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesProfessional testing

Manufacturer: Lin-Zhi International, Inc.
Manufacturer SRN: US-MF-000003373
UDI-DI: 00850624008070
Basic UDI-DI: 0850624008CCBUP02Y8
Reference: 08356661190
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 16.07.2026 06:33

Manufacturer products Authorised representative products Authorised representative actors View details

Fentanyl Qualitative Calibrator Set

Fentanyl Calibrators and Controls

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesProfessional testing

Manufacturer: Lin-Zhi International, Inc.
Manufacturer SRN: US-MF-000003373
UDI-DI: 00850624008278
Basic UDI-DI: 0850624008CCFEN2024V
Reference: 09330097190
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 16.07.2026 06:33

Manufacturer products Authorised representative products Authorised representative actors View details

Buprenorphine Enzyme Immunoassay

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use

Manufacturer: Lin-Zhi International, Inc.
Manufacturer SRN: US-MF-000003373
UDI-DI: 00850624008018
Basic UDI-DI: 0850624008EIABUP02C9
Reference: 08362955190
EMDN: W0102090117
EMDN description: BUPRENORPHINE
First on market country: France
Authorised representative: AR Experts B.V.
Last updated: 16.07.2026 06:33

Manufacturer products Authorised representative products Authorised representative actors View details

6-Acetylmorphine Enzyme Immunoassay

08240035190

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use

Manufacturer: Lin-Zhi International, Inc.
Manufacturer SRN: US-MF-000003373
UDI-DI: 00850624008001
Basic UDI-DI: 0850624008EIA6AM023M
Reference: 08240035190
EMDN: W0102090116
EMDN description: 6-ACETHYLMORPHIUM
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 16.07.2026 06:33

Manufacturer products Authorised representative products Authorised representative actors View details

Zendura

Zendura TRAK

Class IMDR 2017/745On the marketSingle use

Manufacturer: Bay Materials LLC
Manufacturer SRN: US-MF-000049150
UDI-DI: 00850016682406
Basic UDI-DI: 08500166820004G9
Reference: 9308
EMDN: Q010499
EMDN description: ORTHODONTIC DEVICES - OTHER
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 16.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

Zendura

Zendura FLX and Zendura VIVA

Class IMDR 2017/745On the marketSingle use

Manufacturer: Bay Materials LLC
Manufacturer SRN: US-MF-000049150
UDI-DI: 00850016682147
Basic UDI-DI: 08500166820003G7
Reference: 9204-20
EMDN: Q010499
EMDN description: ORTHODONTIC DEVICES - OTHER
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 16.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

Zendura

Zendura AT

Class IMDR 2017/745On the marketSingle use

Manufacturer: Bay Materials LLC
Manufacturer SRN: US-MF-000049150
UDI-DI: 00850016682116
Basic UDI-DI: 08500166820002G5
Reference: 9206-20
EMDN: Q010499
EMDN description: ORTHODONTIC DEVICES - OTHER
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 16.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

Zendura

Zendura A

Class IMDR 2017/745On the marketSingle use

Manufacturer: Bay Materials LLC
Manufacturer SRN: US-MF-000049150
UDI-DI: 00850016682031
Basic UDI-DI: 08500166820001G3
Reference: 9156-20
EMDN: Q010499
EMDN description: ORTHODONTIC DEVICES - OTHER
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 16.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

Neoprobe® Gamma Detection System

Check source holder

Class IMDR 2017/745On the marketActive device

Manufacturer: Devicor Medical Products, Inc.
Manufacturer SRN: US-MF-000003322
UDI-DI: 00841911102786
Basic UDI-DI: 08419111AD03F000003322V6
Reference: P-405
EMDN: Z129099
EMDN description: VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - OTHER
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 16.07.2026 05:14

Manufacturer products Authorised representative products Authorised representative actors View details

Mammotome Revolve™ EX Dual Vacuum-Assisted Biopsy System

Holster Holder

Class IMDR 2017/745On the market

Manufacturer: Devicor Medical Products, Inc.
Manufacturer SRN: US-MF-000003322
UDI-DI: 00841911102366
Basic UDI-DI: 08419111AD02H000003322VZ
Reference: MHEXHOLD1
EMDN: A019012
EMDN description: BREAST NODULES AND OTHER STRUCTURES LOCALISATION NEEDLES AND SYSTEMS
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 16.07.2026 05:14

Manufacturer products Authorised representative products Authorised representative actors View details

Mammotome Revolve™ Dual Vacuum-Assisted Breast Biopsy System

Remote Keypad

Class IMDR 2017/745On the marketActive device

Manufacturer: Devicor Medical Products, Inc.
Manufacturer SRN: US-MF-000003322
UDI-DI: 00841911101871
Basic UDI-DI: 08419111AD02F000003322U7
Reference: MHKEYP1
EMDN: A019012
EMDN description: BREAST NODULES AND OTHER STRUCTURES LOCALISATION NEEDLES AND SYSTEMS
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 16.07.2026 05:14

Manufacturer products Authorised representative products Authorised representative actors View details

Mammotome Revolve™ Dual Vacuum-Assisted Breast Biopsy System

Specimen Management System

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: Devicor Medical Products, Inc.
Manufacturer SRN: US-MF-000003322
UDI-DI: 00841911100836
Basic UDI-DI: 08419111AD02D000003322SD
Reference: MSMB1208
EMDN: A019012
EMDN description: BREAST NODULES AND OTHER STRUCTURES LOCALISATION NEEDLES AND SYSTEMS
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 16.07.2026 05:13

Manufacturer products Authorised representative products Authorised representative actors View details

Mammotome Revolve™ Dual Vacuum-Assisted Breast Biopsy System

Probe Guide

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: Devicor Medical Products, Inc.
Manufacturer SRN: US-MF-000003322
UDI-DI: 00841911100775
Basic UDI-DI: 08419111AD02E000003322TA
Reference: MG08A
EMDN: A019012
EMDN description: BREAST NODULES AND OTHER STRUCTURES LOCALISATION NEEDLES AND SYSTEMS
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 16.07.2026 05:13

Manufacturer products Authorised representative products Authorised representative actors View details

Mammotome Revolve™ Dual Vacuum-Assisted Breast Biopsy System

Control Module

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Devicor Medical Products, Inc.
Manufacturer SRN: US-MF-000003322
UDI-DI: 00841911100690
Basic UDI-DI: 08419111AD02A000003322PN
Reference: MSCM1
EMDN: A019012
EMDN description: BREAST NODULES AND OTHER STRUCTURES LOCALISATION NEEDLES AND SYSTEMS
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 16.07.2026 05:13

Manufacturer products Authorised representative products Authorised representative actors View details

Mammotome Revolve™ Dual Vacuum-Assisted Breast Biopsy System

Holster

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Devicor Medical Products, Inc.
Manufacturer SRN: US-MF-000003322
UDI-DI: 00841911100683
Basic UDI-DI: 08419111AD02B000003322QK
Reference: MHUSH1
EMDN: A019012
EMDN description: BREAST NODULES AND OTHER STRUCTURES LOCALISATION NEEDLES AND SYSTEMS
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 16.07.2026 05:13

Manufacturer products Authorised representative products Authorised representative actors View details

Mammotome Revolve™ Dual Vacuum-Assisted Biopsy System

Footswitch

Class IMDR 2017/745On the marketActive device

Manufacturer: Devicor Medical Products, Inc.
Manufacturer SRN: US-MF-000003322
UDI-DI: 00841911100669
Basic UDI-DI: 08419111AD02G000003322V4
Reference: MFOOT1
EMDN: A019012
EMDN description: BREAST NODULES AND OTHER STRUCTURES LOCALISATION NEEDLES AND SYSTEMS
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 16.07.2026 05:13

Manufacturer products Authorised representative products Authorised representative actors View details

Mammotome Revolve™ Dual Vacuum-Assisted Biopsy System

Cart

Class IMDR 2017/745On the market

Manufacturer: Devicor Medical Products, Inc.
Manufacturer SRN: US-MF-000003322
UDI-DI: 00841911100652
Basic UDI-DI: 08419111AD02I000003322WW
Reference: MCART1
EMDN: A019012
EMDN description: BREAST NODULES AND OTHER STRUCTURES LOCALISATION NEEDLES AND SYSTEMS
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 16.07.2026 05:13

Manufacturer products Authorised representative products Authorised representative actors View details

Neoprobe® Gamma Detection System

Probe cable

Class IMDR 2017/745On the marketActive device

Manufacturer: Devicor Medical Products, Inc.
Manufacturer SRN: US-MF-000003322
UDI-DI: 00841911100249
Basic UDI-DI: 08419111AD03G000003322W3
Reference: NPA76
EMDN: Z129099
EMDN description: VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - OTHER
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 16.07.2026 05:13

Manufacturer products Authorised representative products Authorised representative actors View details