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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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Mouthpiece and Filter ABC

Class IIaMDR 2017/745On the marketDirect markingSingle use

Manufacturer: Aktina Medical Corp
Manufacturer SRN: US-MF-000005935
UDI-DI: +B3651120008011
Basic UDI-DI: ++B3651120008ABCVW
Reference: 11-200-08-01
EMDN: Z11010185
EMDN description: LINEAR ACCELERATORS - CONSUMABLES
First on market country: Austria
Authorised representative: European Healthcare & Device Solutions Ltd.
Last updated: 15.07.2026 14:47

Manufacturer products Authorised representative products Authorised representative actors View details

OI-genomic profiling assay

IVD generalIVDDOn the marketProfessional testingSingle use

Manufacturer: Laboratory Corporation of America Holdings
Manufacturer SRN: US-MF-000017722
UDI-DI: D-US-MF-000017722U2
Basic UDI-DI: B-US-MF-000017722U2
Reference: OI-GPA
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Austria
Authorised representative: European Healthcare & Device Solutions Ltd.
Last updated: 15.07.2026 11:34

Manufacturer products Authorised representative products Authorised representative actors View details

D-TSO500LDTJF

TruSight Oncology 500 LDT Assay (TS0500)

IVD generalIVDDOn the market

Manufacturer: Laboratory Corporation of America Holdings
Manufacturer SRN: US-MF-000017722
UDI-DI: D-TSO500LDTJF
Basic UDI-DI: B-TSO500LDTJF
Reference: TSO500LDT
EMDN: W0599
EMDN description: IVD GENERAL USE CONSUMABLE DEVICES - OTHER
First on market country: Austria
Authorised representative: European Healthcare & Device Solutions Ltd.
Last updated: 15.07.2026 11:23

Manufacturer products Authorised representative products Authorised representative actors View details

nAbCyte Anti-AAVRh74var HB-FE Assay

nAbCyte Anti-AAVRh74var HB-FE Assay 81-Test Device Kit

IVD generalIVDDOn the marketAnimal tissuesCompanion diagnosticsHuman tissuesKitMicrobial substancesProfessional testingSingle useSterile

Manufacturer: Laboratory Corporation of America Holdings
Manufacturer SRN: US-MF-000017722
UDI-DI: D-AntiSpark100nAbAssay8B
Basic UDI-DI: B-AntiSpark100nAbAssay8B
Reference: Anti-Spark 100 nAb Assay
EMDN: W0102010199
EMDN description: IMMUNOGLOBULINS - OTHER
First on market country: Austria
Authorised representative: European Healthcare & Device Solutions Ltd.
Last updated: 12.07.2026 21:46

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Anti-AAv9 nAb

Anti-AAV9 nAb Assay

IVD generalIVDDOn the marketAnimal tissuesCompanion diagnosticsHuman tissuesKitMicrobial substancesSingle useSterile

Manufacturer: Laboratory Corporation of America Holdings
Manufacturer SRN: US-MF-000017722
UDI-DI: D-Anti-AAV9nAbAssayNS
Basic UDI-DI: B-Anti-AAV9nAbAssayNS
Reference: Anti-AAV9 nAb
EMDN: W0102010199
EMDN description: IMMUNOGLOBULINS - OTHER
First on market country: Austria
Authorised representative: European Healthcare & Device Solutions Ltd.
Last updated: 12.07.2026 21:46

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-AAV6 nAb Assay

IVD generalIVDDOn the marketAnimal tissuesCompanion diagnosticsHuman tissuesKitMicrobial substancesSingle useSterile

Manufacturer: Laboratory Corporation of America Holdings
Manufacturer SRN: US-MF-000017722
UDI-DI: D-Anti-AAV6nAbAssayLM
Basic UDI-DI: B-Anti-AAV6nAbAssayLM
Reference: Anti-AAV6 nAb Assay
EMDN: W0102010199
EMDN description: IMMUNOGLOBULINS - OTHER
First on market country: Austria
Authorised representative: European Healthcare & Device Solutions Ltd.
Last updated: 12.07.2026 21:46

Manufacturer products Authorised representative products Authorised representative actors View details

B408IF20

iUFlow

Class IMDDOn the marketActive deviceMeasuring function

Manufacturer: Kesem Health Pty Ltd
Manufacturer SRN: AU-MF-000019211
UDI-DI: B408IF20
Basic UDI-DI: B-B408IF20
Reference: IF2
EMDN: U0599
EMDN description: URODYNAMICS DEVICES - OTHER
First on market country: Italy
Authorised representative: European Healthcare & Device Solutions Ltd.
Last updated: 12.07.2026 21:42

Manufacturer products Authorised representative products Authorised representative actors View details

D-APOL1_80-061-00TX

APOL1 Genotyping Test

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Laboratory Corporation of America Holdings
Manufacturer SRN: US-MF-000017722
UDI-DI: D-APOL1_80-061-00TX
Basic UDI-DI: B-APOL1_80-061-00TX
Reference: 80-061-00
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Austria
Authorised representative: European Healthcare & Device Solutions Ltd.
Last updated: 12.07.2026 21:36

Manufacturer products Authorised representative products Authorised representative actors View details

D-820133-1652G

ApoE Genotype Test

IVD generalIVDDOn the marketCompanion diagnosticsHuman tissuesProfessional testing

Manufacturer: Laboratory Corporation of America Holdings
Manufacturer SRN: US-MF-000017722
UDI-DI: D-820133-1652G
Basic UDI-DI: B-820133-1652G
Reference: 820133-165
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: France
Authorised representative: European Healthcare & Device Solutions Ltd.
Last updated: 12.07.2026 10:06

Manufacturer products Authorised representative products Authorised representative actors View details

OI-immune profiling assay

IVD generalIVDDOn the market

Manufacturer: Laboratory Corporation of America Holdings
Manufacturer SRN: US-MF-000017722
UDI-DI: D-7465934594DH
Basic UDI-DI: B-7465934594DH
Reference: OI-IPA
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Austria
Authorised representative: European Healthcare & Device Solutions Ltd.
Last updated: 12.07.2026 09:09

Manufacturer products Authorised representative products Authorised representative actors View details

Cosil Instruments Company

Single Use Electrosurgery Forceps

Class IIbMDDOn the marketActive deviceSingle useSterile

Manufacturer: Cosil Instruments Company
Manufacturer SRN: PK-MF-000049913
UDI-DI: 08964002499939
Basic UDI-DI: B-08964002499939
Reference: CSUX1XX
EMDN: K0201010601
EMDN description: OPEN ELECTROSURGERY FORCEPS, SINGLE-USE
First on market country: Austria
Authorised representative: European Healthcare & Device Solutions Ltd.
Last updated: 10.07.2026 22:26

Manufacturer products Authorised representative products Authorised representative actors View details

08964000797082

DT-99001-1

Class IMDDOn the marketSingle use

Manufacturer: Electro Range MFG Co
Manufacturer SRN: PK-MF-000036519
UDI-DI: 08964000797082
Basic UDI-DI: B-08964000797082
Reference: DT-99001-1
EMDN: Q010508
EMDN description: DENTAL SURGERY INSTRUMENT KITS, SINGLE-USE
First on market country: Austria
Authorised representative: European Healthcare & Device Solutions Ltd.
Last updated: 10.07.2026 22:22

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08964000797075

GR-91661-1

Class IMDDOn the marketSingle use

Manufacturer: Electro Range MFG Co
Manufacturer SRN: PK-MF-000036519
UDI-DI: 08964000797075
Basic UDI-DI: B-08964000797075
Reference: GR-91661-1
EMDN: N02800201
EMDN description: SPINAL MEDULLARY SYSTEM SURGICAL FORCEPS, SINGLE-USE
First on market country: Austria
Authorised representative: European Healthcare & Device Solutions Ltd.
Last updated: 10.07.2026 22:22

Manufacturer products Authorised representative products Authorised representative actors View details

ERMC

ERMC: D1400 Series

Class IMDDOn the marketActive deviceSingle useSterile

Manufacturer: Electro Range MFG Co
Manufacturer SRN: PK-MF-000036519
UDI-DI: 08964000797068
Basic UDI-DI: B-08964000797068
Reference: ERMC: D1400 Series
EMDN: K02010203
EMDN description: ELECTROSURGERY CONNECTION CABLES, SINGLE-USE
First on market country: Austria
Authorised representative: European Healthcare & Device Solutions Ltd.
Last updated: 10.07.2026 22:22

Manufacturer products Authorised representative products Authorised representative actors View details

ERMC

ERMC: E101X-300X

Class IIbMDDOn the marketActive deviceReusable

Manufacturer: Electro Range MFG Co
Manufacturer SRN: PK-MF-000036519
UDI-DI: 08964000797051
Basic UDI-DI: B-08964000797051
Reference: ERMC: E101X-300X
EMDN: L180601
EMDN description: OPEN ELECTROSURGERY ELECTRODES, REUSABLE
First on market country: Austria
Authorised representative: European Healthcare & Device Solutions Ltd.
Last updated: 10.07.2026 22:22

Manufacturer products Authorised representative products Authorised representative actors View details

ERMC

ERMC: D601X-301X

Class IIbMDDOn the marketActive deviceReusableSingle useSterile

Manufacturer: Electro Range MFG Co
Manufacturer SRN: PK-MF-000036519
UDI-DI: 08964000797044
Basic UDI-DI: B-08964000797044
Reference: ERMC: D601X-301X
EMDN: K0201010301
EMDN description: OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE
First on market country: Austria
Authorised representative: European Healthcare & Device Solutions Ltd.
Last updated: 10.07.2026 22:22

Manufacturer products Authorised representative products Authorised representative actors View details

ERMC

ERMC: 1200Series

Class IIbMDDOn the marketActive deviceReusable

Manufacturer: Electro Range MFG Co
Manufacturer SRN: PK-MF-000036519
UDI-DI: 08964000797037
Basic UDI-DI: B-08964000797037
Reference: ERMC: 1200Series
EMDN: L180401
EMDN description: OPEN ELECTROSURGERY FORCEPS, REUSABLE
First on market country: Austria
Authorised representative: European Healthcare & Device Solutions Ltd.
Last updated: 10.07.2026 22:22

Manufacturer products Authorised representative products Authorised representative actors View details

ERMC

ERMC: NA401XX

Class IIbMDDOn the marketActive deviceSingle useSterile

Manufacturer: Electro Range MFG Co
Manufacturer SRN: PK-MF-000036519
UDI-DI: 08964000797020
Basic UDI-DI: B-08964000797020
Reference: ERMC: NA401XX
EMDN: K0201010601
EMDN description: OPEN ELECTROSURGERY FORCEPS, SINGLE-USE
First on market country: Austria
Authorised representative: European Healthcare & Device Solutions Ltd.
Last updated: 10.07.2026 22:22

Manufacturer products Authorised representative products Authorised representative actors View details

ERMC

PT101XX

Class IIbMDDOn the marketActive deviceReusable

Manufacturer: Electro Range MFG Co
Manufacturer SRN: PK-MF-000036519
UDI-DI: 08964000797013
Basic UDI-DI: B-08964000797013
Reference: ERMC: PT101XX
EMDN: L180401
EMDN description: OPEN ELECTROSURGERY FORCEPS, REUSABLE
First on market country: Austria
Authorised representative: European Healthcare & Device Solutions Ltd.
Last updated: 10.07.2026 22:22

Manufacturer products Authorised representative products Authorised representative actors View details

ERMC

NA101XX

Class IIbMDDOn the marketActive deviceSingle useSterile

Manufacturer: Electro Range MFG Co
Manufacturer SRN: PK-MF-000036519
UDI-DI: 08964000797006
Basic UDI-DI: B-08964000797006
Reference: ERMC: NA101XX
EMDN: K0201010601
EMDN description: OPEN ELECTROSURGERY FORCEPS, SINGLE-USE
First on market country: Austria
Authorised representative: European Healthcare & Device Solutions Ltd.
Last updated: 10.07.2026 22:22

Manufacturer products Authorised representative products Authorised representative actors View details