Public EUDAMED Search

EUDAMED Device Search

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

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iSWAB

iSWAB RNA v2 Collection Device

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Mawi DNA Technologies, LLC
Manufacturer SRN: US-MF-000023207
UDI-DI: 00850040712087
Basic UDI-DI: 850040712001ISWAB-RNA6H
Reference: ISWAB-RNA-v2
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Northern Ireland
Authorised representative: CEpartner4U
Last updated: 03.07.2026 15:24

Manufacturer products Authorised representative products Authorised representative actors View details

iSWAB-ID

iSWAB-ID Human DNA Collection Device

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Mawi DNA Technologies, LLC
Manufacturer SRN: US-MF-000023207
UDI-DI: 00850040712056
Basic UDI-DI: 850040712ISWAB-IDNR
Reference: ISWAB-ID-250
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Northern Ireland
Authorised representative: CEpartner4U
Last updated: 03.07.2026 15:24

Manufacturer products Authorised representative products Authorised representative actors View details

iSWAB-Discovery

iSWAB-Discovery Human DNA Collection Device

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Mawi DNA Technologies, LLC
Manufacturer SRN: US-MF-000023207
UDI-DI: 00850040712049
Basic UDI-DI: 850040712001ISWAB-DSC4W
Reference: ISWAB-DSC
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Northern Ireland
Authorised representative: CEpartner4U
Last updated: 03.07.2026 15:24

Manufacturer products Authorised representative products Authorised representative actors View details

iSWAB

iSWAB DNA Collection Device

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Mawi DNA Technologies, LLC
Manufacturer SRN: US-MF-000023207
UDI-DI: 00850040712001
Basic UDI-DI: 850040712001ISWAB-DNA4B
Reference: ISWAB-DNA-1200
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Northern Ireland
Authorised representative: CEpartner4U
Last updated: 03.07.2026 15:24

Manufacturer products Authorised representative products Authorised representative actors View details

Prostate Kit

Receptacles

IVD Class AIVDR 2017/746On the marketKitReagentSingle use

Manufacturer: Leica Biosystems Richmond, Inc
Manufacturer SRN: US-MF-000014614
UDI-DI: 00849832023036
Basic UDI-DI: 849832004UM
Reference: 3800850
EMDN: W0599
EMDN description: IVD GENERAL USE CONSUMABLE DEVICES - OTHER
First on market country: Netherlands
Authorised representative: CEpartner4U
Last updated: 03.07.2026 15:23

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue Freezing Medium

Frozen Section Compound

IVD Class AIVDR 2017/746On the marketDirect markingReagent

Manufacturer: Leica Biosystems Richmond, Inc
Manufacturer SRN: US-MF-000014614
UDI-DI: 00849832012214
Basic UDI-DI: 849832005UP
Reference: 14020108926
EMDN: W0599
EMDN description: IVD GENERAL USE CONSUMABLE DEVICES - OTHER
First on market country: Netherlands
Authorised representative: CEpartner4U
Last updated: 03.07.2026 15:23

Manufacturer products Authorised representative products Authorised representative actors View details

00841439112489

Stereotactic Radiosurgery and Stereotactic Radiotherapy Devices

Class IMDR 2017/745On the marketReusable

Manufacturer: Medtec LLC
Manufacturer SRN: US-MF-000002608
UDI-DI: 00841439112489
Basic UDI-DI: 8414391OC0019R01BX
Reference: CHS03
EMDN: Z12011299
EMDN description: PATIENT POSITIONING INSTRUMENTS – OTHER
First on market country: Netherlands
Authorised representative: CEpartner4U
Last updated: 03.07.2026 12:57

Manufacturer products Authorised representative products Authorised representative actors View details

00841439111345

Thermoplastic Devices

Class IMDR 2017/745On the marketReusable

Manufacturer: Medtec LLC
Manufacturer SRN: US-MF-000002608
UDI-DI: 00841439111345
Basic UDI-DI: 8414391OC0003R13AH
Reference: MTRH1500EX
EMDN: Y0699
EMDN description: EXTERNAL PROSTHESES AND ORTHOSES - OTHER
First on market country: Netherlands
Authorised representative: CEpartner4U
Last updated: 03.07.2026 12:57

Manufacturer products Authorised representative products Authorised representative actors View details

00841439109588

Sterile Fiducial Marker Kits (Class IIb)

Class IIbMDR 2017/745On the marketSterile

Manufacturer: Medtec LLC
Manufacturer SRN: US-MF-000002608
UDI-DI: 00841439109588
Basic UDI-DI: 8414391OC0015R08BH
Reference: MTNW887358
EMDN: Z11039080
EMDN description: VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: CEpartner4U
Last updated: 03.07.2026 12:57

Manufacturer products Authorised representative products Authorised representative actors View details

00841439108697

Vac-Lok Cushions

Class IMDR 2017/745On the marketReusable

Manufacturer: Medtec LLC
Manufacturer SRN: US-MF-000002608
UDI-DI: 00841439108697
Basic UDI-DI: 8414391OC0018R13BX
Reference: MTVP1
EMDN: Z12011299
EMDN description: PATIENT POSITIONING INSTRUMENTS – OTHER
First on market country: Netherlands
Authorised representative: CEpartner4U
Last updated: 03.07.2026 12:57

Manufacturer products Authorised representative products Authorised representative actors View details

00841439108512

Vac-Lok Cushions

Class IMDR 2017/745On the marketReusable

Manufacturer: Medtec LLC
Manufacturer SRN: US-MF-000002608
UDI-DI: 00841439108512
Basic UDI-DI: 8414391OC0018R01BQ
Reference: MTVLHH150
EMDN: Z12011299
EMDN description: PATIENT POSITIONING INSTRUMENTS – OTHER
First on market country: Netherlands
Authorised representative: CEpartner4U
Last updated: 03.07.2026 12:57

Manufacturer products Authorised representative products Authorised representative actors View details

00841439104064

Head, Neck, and Shoulder Devices

Class IMDR 2017/745On the marketReusable

Manufacturer: Medtec LLC
Manufacturer SRN: US-MF-000002608
UDI-DI: 00841439104064
Basic UDI-DI: 8414391OC0005R05AY
Reference: MTCBPBITE
EMDN: Z12011299
EMDN description: PATIENT POSITIONING INSTRUMENTS – OTHER
First on market country: Netherlands
Authorised representative: CEpartner4U
Last updated: 03.07.2026 12:57

Manufacturer products Authorised representative products Authorised representative actors View details

00841439102275

Stereotactic Body Radiation Therapy (SBRT)

Class IMDR 2017/745On the marketReusable

Manufacturer: Medtec LLC
Manufacturer SRN: US-MF-000002608
UDI-DI: 00841439102275
Basic UDI-DI: 8414391OC0017R01BH
Reference: BPL001
EMDN: Z12011299
EMDN description: PATIENT POSITIONING INSTRUMENTS – OTHER
First on market country: Netherlands
Authorised representative: CEpartner4U
Last updated: 03.07.2026 12:57

Manufacturer products Authorised representative products Authorised representative actors View details

00841439102190

Couchtop

Class IMDR 2017/745On the market

Manufacturer: Medtec LLC
Manufacturer SRN: US-MF-000002608
UDI-DI: 00841439102190
Basic UDI-DI: 8414391OC0007R01B6
Reference: 20VARSUB10
EMDN: Z12011299
EMDN description: PATIENT POSITIONING INSTRUMENTS – OTHER
First on market country: Netherlands
Authorised representative: CEpartner4U
Last updated: 03.07.2026 12:56

Manufacturer products Authorised representative products Authorised representative actors View details

00841439102008

Thermoplastic Devices

Class IMDR 2017/745On the marketReusable

Manufacturer: Medtec LLC
Manufacturer SRN: US-MF-000002608
UDI-DI: 00841439102008
Basic UDI-DI: 8414391OC0003R01AA
Reference: 20CFHNPSUB1P
EMDN: Z12011299
EMDN description: PATIENT POSITIONING INSTRUMENTS – OTHER
First on market country: Netherlands
Authorised representative: CEpartner4U
Last updated: 03.07.2026 12:56

Manufacturer products Authorised representative products Authorised representative actors View details

00841439101162

Breast Positioning Devices

Class IMDR 2017/745On the marketReusable

Manufacturer: Medtec LLC
Manufacturer SRN: US-MF-000002608
UDI-DI: 00841439101162
Basic UDI-DI: 8414391OC0010R019Y
Reference: 301080
EMDN: Z12011280
EMDN description: PATIENT POSITIONING INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: CEpartner4U
Last updated: 03.07.2026 12:56

Manufacturer products Authorised representative products Authorised representative actors View details

00841439101070

Hip and Pelvis Devices

Class IMDR 2017/745On the market

Manufacturer: Medtec LLC
Manufacturer SRN: US-MF-000002608
UDI-DI: 00841439101070
Basic UDI-DI: 8414391OC0011R01A7
Reference: 301052
EMDN: Z12011280
EMDN description: PATIENT POSITIONING INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: CEpartner4U
Last updated: 03.07.2026 12:56

Manufacturer products Authorised representative products Authorised representative actors View details

00841439100141

Head, Neck, and Shoulder Devices

Class IMDR 2017/745On the marketReusable

Manufacturer: Medtec LLC
Manufacturer SRN: US-MF-000002608
UDI-DI: 00841439100141
Basic UDI-DI: 8414391OC0005R01AQ
Reference: 101019
EMDN: Z12011280
EMDN description: PATIENT POSITIONING INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: CEpartner4U
Last updated: 03.07.2026 12:56

Manufacturer products Authorised representative products Authorised representative actors View details

Monarch

Braille device

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Technologies HumanWare Inc.
Manufacturer SRN: CA-MF-000022852
UDI-DI: 18306110001166
Basic UDI-DI: 83061100001J9
Reference: BNP480 - FGBR-1201
EMDN: Y210999
EMDN description: PERSONAL COMPUTER INPUT AND OUTPUT PERIPHERAL EQUIPMENT - OTHER
First on market country: France
Authorised representative: CEpartner4U
Last updated: 03.07.2026 12:49

Manufacturer products Authorised representative products Authorised representative actors View details

Stellar Trek

Class IMDR 2017/745On the market

Manufacturer: Technologies HumanWare Inc.
Manufacturer SRN: CA-MF-000022852
UDI-DI: 18306110000893
Basic UDI-DI: 83061100004JF
Reference: FGAB-0001
EMDN: Y1299
EMDN description: PERSONAL MOBILITY DEVICES - OTHER
First on market country: France
Authorised representative: CEpartner4U
Last updated: 03.07.2026 12:49

Manufacturer products Authorised representative products Authorised representative actors View details