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EUDAMED Device Search

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

Last updated

17.07.2026 02:09

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0101

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357000047
Basic UDI-DI: 0845357001018T
Reference: [0101U] KWIK-STIK™ S. zooepidemicus ATCC 43079™
EMDN: W01040601
EMDN description: QC STRAINS BACTERIOLOGY
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:23

Manufacturer products Authorised representative products Authorised representative actors View details

Streck Urine Preserve CE

Streck Urine Preserve CE

IVD Class AIVDR 2017/746On the marketReagent

Manufacturer: Streck
Manufacturer SRN: US-MF-000013009
UDI-DI: 00844509002390
Basic UDI-DI: 08445090UPCENV
Reference: 230631
EMDN: W0580
EMDN description: IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:20

Manufacturer products Authorised representative products Authorised representative actors View details

230200

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testing

Manufacturer: Streck
Manufacturer SRN: US-MF-000013009
UDI-DI: 00844509001898
Basic UDI-DI: 08445090SPVCQ4
Reference: 230200
EMDN: W05039099
EMDN description: DEVICES FOR SAMPLES ANALYSES - OTHER
First on market country: Germany
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:20

Manufacturer products Authorised representative products Authorised representative actors View details

230202

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testing

Manufacturer: Streck
Manufacturer SRN: US-MF-000013009
UDI-DI: 00844509001867
Basic UDI-DI: 08445090SPCWT
Reference: 230202
EMDN: W05039099
EMDN description: DEVICES FOR SAMPLES ANALYSES - OTHER
First on market country: Germany
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:20

Manufacturer products Authorised representative products Authorised representative actors View details

218750

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testing

Manufacturer: Streck
Manufacturer SRN: US-MF-000013009
UDI-DI: 00844509000648
Basic UDI-DI: 0844509012EXT5Y
Reference: 218750
EMDN: W0103010503
EMDN description: MULTILEVEL BLOOD CONTROLS
First on market country: Germany
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:20

Manufacturer products Authorised representative products Authorised representative actors View details

225480

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testing

Manufacturer: Streck
Manufacturer SRN: US-MF-000013009
UDI-DI: 00844509000358
Basic UDI-DI: 08445090STKRQM
Reference: 225485
EMDN: W0103010503
EMDN description: MULTILEVEL BLOOD CONTROLS
First on market country: Germany
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:20

Manufacturer products Authorised representative products Authorised representative actors View details

212431

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testing

Manufacturer: Streck
Manufacturer SRN: US-MF-000013009
UDI-DI: 00844509000280
Basic UDI-DI: 08445090CX8Z
Reference: 212420
EMDN: W0103010501
EMDN description: NORMAL BLOOD CONTROLS
First on market country: Germany
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:20

Manufacturer products Authorised representative products Authorised representative actors View details

Para 12 Plus

IVD Class BIVDR 2017/746On the marketHuman tissues

Manufacturer: Streck
Manufacturer SRN: US-MF-000013009
UDI-DI: 00844509000211
Basic UDI-DI: 0844509012+MH
Reference: 218924
EMDN: W0202010185
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:20

Manufacturer products Authorised representative products Authorised representative actors View details

LIFECARD CF DIGITAL HOLTER MON

Lifecard

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Spacelabs Healthcare Ltd
Manufacturer SRN: GB-MF-000001196
UDI-DI: 10841522131097
Basic UDI-DI: 08415221ICFCLCFOEM8P
Reference: LCF
EMDN: Z12050404
EMDN description: BLOOD PRESSURE HOLTER RECORDERS
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:16

Manufacturer products Authorised representative products Authorised representative actors View details

Eclipse Mini

Class IMDR 2017/745On the marketActive device

Manufacturer: Spacelabs Healthcare Ltd
Manufacturer SRN: GB-MF-000001196
UDI-DI: 10841522130304
Basic UDI-DI: 08415221IEMPATCHOWNBU
Reference: 712-1053-01
EMDN: Z12050485
EMDN description: HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - CONSUMABLES
First on market country: Germany
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:16

Manufacturer products Authorised representative products Authorised representative actors View details

ECLIPSE PRO RECORDER,MULTILINGUAL

Eclipse Pro

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Spacelabs Healthcare Ltd
Manufacturer SRN: GB-MF-000001196
UDI-DI: 10841522128851
Basic UDI-DI: 08415221IIa98700OWNJ9
Reference: 98700
EMDN: Z12050403
EMDN description: ECG HOLTER RECORDERS
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:16

Manufacturer products Authorised representative products Authorised representative actors View details

LIFESCREEN PRO ANALYSER, V1.X

Lifescreen Pro

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Spacelabs Healthcare Ltd
Manufacturer SRN: GB-MF-000001196
UDI-DI: 10841522128837
Basic UDI-DI: 08415221IIa98800OWNJN
Reference: LSPRO
EMDN: Z12050401
EMDN description: CARDIOVASCULAR HOLTER ANALYSERS
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:16

Manufacturer products Authorised representative products Authorised representative actors View details

ECLIPSE MINI RECORDER, MULTILINGUAL

Eclipse Mini

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Spacelabs Healthcare Ltd
Manufacturer SRN: GB-MF-000001196
UDI-DI: 10841522128769
Basic UDI-DI: 08415221IIa98900OWNK3
Reference: 98900
EMDN: Z12050403
EMDN description: ECG HOLTER RECORDERS
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:16

Manufacturer products Authorised representative products Authorised representative actors View details

ECLIPSE PRO,CABLE,PX,3 SNAP,LONG

Eclipse Pro cables and patches

Class IMDR 2017/745On the marketActive device

Manufacturer: Spacelabs Healthcare Ltd
Manufacturer SRN: GB-MF-000001196
UDI-DI: 10841522127236
Basic UDI-DI: 08415221IEPROC&POWN7U
Reference: 700-0372-00
EMDN: Z12050485
EMDN description: HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - CONSUMABLES
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:16

Manufacturer products Authorised representative products Authorised representative actors View details

ABP ULTRALITE MONITOR, GERMAN

Ultralite

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Spacelabs Healthcare Ltd
Manufacturer SRN: GB-MF-000001196
UDI-DI: 10841522126857
Basic UDI-DI: 08415221IIa90217AOWN25
Reference: 90217A-2
EMDN: Z12050404
EMDN description: BLOOD PRESSURE HOLTER RECORDERS
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:16

Manufacturer products Authorised representative products Authorised representative actors View details

PATHFINDER SL HOLTER ANALYSIS SYSTEM (ENGLISH)

Pathfinder SL

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Spacelabs Healthcare Ltd
Manufacturer SRN: GB-MF-000001196
UDI-DI: 10841522126000
Basic UDI-DI: 08415221IIa98000OWNFE
Reference: 98000-01
EMDN: Z12050401
EMDN description: CARDIOVASCULAR HOLTER ANALYSERS
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:16

Manufacturer products Authorised representative products Authorised representative actors View details

SENTINEL SOFTWARE V11

Sentinel 11

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Spacelabs Healthcare Ltd
Manufacturer SRN: GB-MF-000001196
UDI-DI: 10841522125751
Basic UDI-DI: 08415221IIa98201OWNGF
Reference: 98201
EMDN: Z12050482
EMDN description: HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - SOFTWARE ACCESSORIES
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:16

Manufacturer products Authorised representative products Authorised representative actors View details

LEADWIRES,SNAP,60CM,6SET,SAFETY,AHA HOLTER CODE

Patient cables & ECG leadwires

Class IMDR 2017/745On the marketActive device

Manufacturer: Spacelabs Healthcare Ltd
Manufacturer SRN: GB-MF-000001196
UDI-DI: 10841522125584
Basic UDI-DI: 08415221IECGCABLEOWN-UKK6
Reference: 19-7509
EMDN: Z12050485
EMDN description: HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - CONSUMABLES
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:16

Manufacturer products Authorised representative products Authorised representative actors View details

EVO DOCKING STATION USB CONN & EU PWR CBL

EVO Docking Station

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Spacelabs Healthcare Ltd
Manufacturer SRN: GB-MF-000001196
UDI-DI: 10841522125430
Basic UDI-DI: 08415221IEVODOCKOWNHX
Reference: 50-0044
EMDN: Z12050499
EMDN description: HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS – OTHER
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:16

Manufacturer products Authorised representative products Authorised representative actors View details

4 ELECTRODE EVO RECORDER PACKED

EVO Recorder

Class IIaMDR 2017/745No longer on the marketActive deviceDirect markingMeasuring function

Manufacturer: Spacelabs Healthcare Ltd
Manufacturer SRN: GB-MF-000001196
UDI-DI: 10841522125133
Basic UDI-DI: 08415221IIaTAYOWNJJ
Reference: 50-0034
EMDN: Z12050403
EMDN description: ECG HOLTER RECORDERS
First on market country: -
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:16

Manufacturer products Authorised representative products Authorised representative actors View details