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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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iSWAB Cells Collection Device

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Mawi DNA Technologies, LLC
Manufacturer SRN: US-MF-000023207
UDI-DI: 00850040712148
Basic UDI-DI: 850040712001ISWAB-CELLSQU
Reference: ISWAB-CELLS-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

iSWAB Microbiome Collection Device

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Mawi DNA Technologies, LLC
Manufacturer SRN: US-MF-000023207
UDI-DI: 00850040712100
Basic UDI-DI: 850040712001iSWAB-MB3J
Reference: iSWAB-MB-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

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 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 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

LetsGetChecked Stool Home Sample Collection Kit

LetsGetChecked Stool Home Sample Collection Kit

IVD Class AIVDR 2017/746On the marketKitSingle use

Manufacturer: PrivaPath Diagnostics Limited
Manufacturer SRN: IE-MF-000045162
UDI-DI: 00850024881259
Basic UDI-DI: 850024881SCT6
Reference: FT01I
EMDN: W05019001
EMDN description: FAECES COLLECTION DEVICES
First on market country: Ireland
Authorised representative: -
Last updated: 03.07.2026 15:24

Manufacturer products View details

The Smart Lollipop One

The Smart Lollipop One

IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: Happy Innova SL
Manufacturer SRN: ES-MF-000048093
UDI-DI: 08437028905000
Basic UDI-DI: 8437028905TSLOCU
Reference: TSLO.000
EMDN: W05019002
EMDN description: SALIVA COLLECTION DEVICES
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 15:18

Manufacturer products View details

EMBRYO BIOPSY KIT (10ud)

Embryo Biopsy Kit

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: JUNO GENETICS ESPAÑA
Manufacturer SRN: ES-MF-000045150
UDI-DI: 08437026899004
Basic UDI-DI: 8437026899EBKE9
Reference: FL1026
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 15:16

Manufacturer products View details

GutAlive

IVD Class AIVDR 2017/746On the marketKitSingle use

Manufacturer: Microviable Therapeutics
Manufacturer SRN: ES-MF-000030013
UDI-DI: 08437025337002
Basic UDI-DI: 8437025337MT0001G7G
Reference: MT0001G
EMDN: W05019001
EMDN description: FAECES COLLECTION DEVICES
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 15:15

Manufacturer products View details

Stool Collection Kit (SCK-CRC)

Stool Collection Kit (SCK-CRC)

IVD Class AIVDR 2017/746On the marketDirect markingKitSingle use

Manufacturer: GOODGUT, SLU
Manufacturer SRN: ES-MF-000000229
UDI-DI: 08437023437070
Basic UDI-DI: 8437023437SCKAT
Reference: SCK-04-CRC-es
EMDN: W05019001
EMDN description: FAECES COLLECTION DEVICES
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 15:12

Manufacturer products View details

KIT AIRTEST 8T FRUCTOSA

-

IVD Class ANot specifiedOn the marketSingle use

Manufacturer: AYALA SAMPLE KITS, S.L.
Manufacturer SRN: ES-MF-000037853
UDI-DI: 08436628290103
Basic UDI-DI: 8437026387AIRTESTT8
Reference: 8ATFRU
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 15:11

Manufacturer products View details

Sample Collection Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: IGENOMIX SPAIN LAB S.L UNIPERSONAL
Manufacturer SRN: ES-MF-000029287
UDI-DI: 08437021231038
Basic UDI-DI: 8437021231P2D8
Reference: P2002
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 15:08

Manufacturer products View details

Sample Collection Kit

IVD Class AIVDR 2017/746On the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: IGENOMIX SPAIN LAB S.L UNIPERSONAL
Manufacturer SRN: ES-MF-000029287
UDI-DI: 08437021231014
Basic UDI-DI: 8437021231P3DA
Reference: P2010
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 15:08

Manufacturer products View details

Sample Collection Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: IGENOMIX SPAIN LAB S.L UNIPERSONAL
Manufacturer SRN: ES-MF-000029287
UDI-DI: 08437021231007
Basic UDI-DI: 8437021231P1D6
Reference: P2000
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 15:08

Manufacturer products View details

DISBIOKIT

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingSingle use

Manufacturer: ISOMED PHARMA, S.L.
Manufacturer SRN: ES-MF-000001341
UDI-DI: 08437019794071
Basic UDI-DI: 8437019794DISBIOKITYT
Reference: 206502.4
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 15:07

Manufacturer products View details

PANCREOKIT

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingSingle use

Manufacturer: ISOMED PHARMA, S.L.
Manufacturer SRN: ES-MF-000001341
UDI-DI: 08437019794064
Basic UDI-DI: 8437019794PANCREOKITW5
Reference: 163631.7
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 15:07

Manufacturer products View details

GASTROKIT

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingSingle use

Manufacturer: ISOMED PHARMA, S.L.
Manufacturer SRN: ES-MF-000001341
UDI-DI: 08437019794057
Basic UDI-DI: 8437019794GASTROKIT8Q
Reference: 163632.4
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 15:07

Manufacturer products View details

PRUEBAS FUNCIONALES

PRUEBAS FUNCIONALES

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingSingle use

Manufacturer: ISOMED PHARMA, S.L.
Manufacturer SRN: ES-MF-000001341
UDI-DI: 08437019794040
Basic UDI-DI: 8437019794PRUEBASFUNCIORH
Reference: 163630.0
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 15:07

Manufacturer products View details

SIBOKIT

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingSingle use

Manufacturer: ISOMED PHARMA, S.L.
Manufacturer SRN: ES-MF-000001341
UDI-DI: 08437019794033
Basic UDI-DI: 8437019794SIBOKIT2L
Reference: 201885.3
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 15:07

Manufacturer products View details