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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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ProciseDx Analyzer

4390

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentNear-patient testingProfessional testing

Manufacturer: ProciseDx Inc.
Manufacturer SRN: US-MF-000040747
UDI-DI: 08100322943909
Basic UDI-DI: 081003229PDXA439022SS
Reference: 4390
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: France
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 03:33

Manufacturer products Authorised representative products Authorised representative actors View details

PALL® STEM CELL PROCESSING SYSTEM

791-02U

Class IIbMDR 2017/745On the marketSingle useSterile

Manufacturer: Pall International SARL
Manufacturer SRN: CH-MF-000023177
UDI-DI: 10636207200317
Basic UDI-DI: 0636207CBLB06NINVU3
Reference: 791-02U
EMDN: B0105
EMDN description: UMBILICAL CORD BLOOD COLLECTION, PURIFICATION, CRYOPRESERVATION BAGS AND KITS
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 01:11

Manufacturer products Authorised representative products Authorised representative actors View details

Pall Nanodyne™ ELD filter

ELD96NTE

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Pall International SARL
Manufacturer SRN: CH-MF-000023177
UDI-DI: 00636207001290
Basic UDI-DI: 0636207IVFC05NINVCL
Reference: ELD96NTE
EMDN: A04010101
EMDN description: WITHDRAWL AND ADMINISTRATION FILTERS (0.2-1.2 MICRONS)
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 01:07

Manufacturer products Authorised representative products Authorised representative actors View details

Colli-Pee® UAS® FV-5040

IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: DNA Genotek Inc.
Manufacturer SRN: CA-MF-000003486
UDI-DI: 00627595001719
Basic UDI-DI: 0627595M1300K4
Reference: N00342
EMDN: W05010299
EMDN description: URINE COLLECTION DEVICES - OTHER
First on market country: Austria
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 01:05

Manufacturer products Authorised representative products Authorised representative actors View details

Colli-Pee® UCM® FV-5020

IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: DNA Genotek Inc.
Manufacturer SRN: CA-MF-000003486
UDI-DI: 00627595001672
Basic UDI-DI: 0627595L1200JL
Reference: N00176
EMDN: W05010299
EMDN description: URINE COLLECTION DEVICES - OTHER
First on market country: Austria
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 01:05

Manufacturer products Authorised representative products Authorised representative actors View details

Colli-Pee® FV-5020

IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: DNA Genotek Inc.
Manufacturer SRN: CA-MF-000003486
UDI-DI: 00627595001627
Basic UDI-DI: 0627595K1100J4
Reference: N00055
EMDN: W05010299
EMDN description: URINE COLLECTION DEVICES - OTHER
First on market country: Austria
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 01:05

Manufacturer products Authorised representative products Authorised representative actors View details

OG-AC1

Class IMDR 2017/745On the marketDirect markingSingle use

Manufacturer: DNA Genotek Inc.
Manufacturer SRN: CA-MF-000003486
UDI-DI: 00627595000682
Basic UDI-DI: 0627595D0400FX
Reference: OG-AC1
EMDN: A1101
EMDN description: SAMPLE COLLECTION NEUTRAL SWABS
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 01:05

Manufacturer products Authorised representative products Authorised representative actors View details

OMNIgene ORAL

IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: DNA Genotek Inc.
Manufacturer SRN: CA-MF-000003486
UDI-DI: 00627595000675
Basic UDI-DI: 0627595F0600GX
Reference: OME-505
EMDN: W05019002
EMDN description: SALIVA COLLECTION DEVICES
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 01:05

Manufacturer products Authorised representative products Authorised representative actors View details

ORAcollect RNA

ORAcollect (Swab based RNA Collection Device)

Class IMDR 2017/745On the marketSingle use

Manufacturer: DNA Genotek Inc.
Manufacturer SRN: CA-MF-000003486
UDI-DI: 00627595000569
Basic UDI-DI: 0627595C0300FF
Reference: ORE-100
EMDN: A1102
EMDN description: SAMPLE COLLECTION SWABS WITH TRANSPORT MEDIUM
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 01:05

Manufacturer products Authorised representative products Authorised representative actors View details

OMNIgene Liquefaction Reagent

IVD Class AIVDR 2017/746On the marketReagent

Manufacturer: DNA Genotek Inc.
Manufacturer SRN: CA-MF-000003486
UDI-DI: 00627595000545
Basic UDI-DI: 0627595I0900JF
Reference: OM-LQR-400
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 01:05

Manufacturer products Authorised representative products Authorised representative actors View details

OMNIgene GUT

IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: DNA Genotek Inc.
Manufacturer SRN: CA-MF-000003486
UDI-DI: 00627595000514
Basic UDI-DI: 0627595G0700HF
Reference: OM-200
EMDN: W05019001
EMDN description: FAECES COLLECTION DEVICES
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 01:05

Manufacturer products Authorised representative products Authorised representative actors View details

PrepIT L2P

IVD Class AIVDR 2017/746On the marketReagent

Manufacturer: DNA Genotek Inc.
Manufacturer SRN: CA-MF-000003486
UDI-DI: 00627595000415
Basic UDI-DI: 0627595H0800HX
Reference: PT-L2P-5
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 01:05

Manufacturer products Authorised representative products Authorised representative actors View details

ORAcollect Dx

ORAcollect (Swab based DNA & Dx Collection Device)

Class IMDR 2017/745No longer on the marketSingle use

Manufacturer: DNA Genotek Inc.
Manufacturer SRN: CA-MF-000003486
UDI-DI: 00627595000309
Basic UDI-DI: 0627595B0200EX
Reference: OCD-100
EMDN: A1102
EMDN description: SAMPLE COLLECTION SWABS WITH TRANSPORT MEDIUM
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 01:05

Manufacturer products Authorised representative products Authorised representative actors View details

ORAgene Dx

ORAgene (Swab-based DNA & Dx Collection Device)

IVD Class AIVDR 2017/746On the marketKitSingle use

Manufacturer: DNA Genotek Inc.
Manufacturer SRN: CA-MF-000003486
UDI-DI: 00627595000224
Basic UDI-DI: 0627595A0100EF
Reference: OGD-575
EMDN: A1101
EMDN description: SAMPLE COLLECTION NEUTRAL SWABS
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 01:05

Manufacturer products Authorised representative products Authorised representative actors View details

ORAgene Dx

ORAgene

IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: DNA Genotek Inc.
Manufacturer SRN: CA-MF-000003486
UDI-DI: 00627595000019
Basic UDI-DI: 0627595E0500GF
Reference: OGD-500
EMDN: W05019002
EMDN description: SALIVA COLLECTION DEVICES
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 01:05

Manufacturer products Authorised representative products Authorised representative actors View details

Intercept i2

3001-2661

IVD Class AIVDR 2017/746No longer on the marketDirect markingProfessional testingReagentSingle use

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 00608337001006
Basic UDI-DI: 0608337300126127F
Reference: 1001-0383
EMDN: W050180
EMDN description: SAMPLES COLLECTION DEVICES - OTHER ACCESSORIES
First on market country: Norway
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 00:53

Manufacturer products Authorised representative products Authorised representative actors View details

05061107470009

IVD Class ANot specifiedOn the marketDirect markingKitSingle use

Manufacturer: Inuvi Health Limited
Manufacturer SRN: UK-MF-000057167
UDI-DI: 05061107470009
Basic UDI-DI: 5061107470009R6
Reference: Inuvi-002/CE
EMDN: -
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 22:56

Manufacturer products Authorised representative products Authorised representative actors View details

05061107470146

IVD Class ANot specifiedOn the marketKit

Manufacturer: Inuvi Health Limited
Manufacturer SRN: UK-MF-000057167
UDI-DI: 05061107470146
Basic UDI-DI: 5061107470146RH
Reference: Inuvi-006/CE
EMDN: -
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 22:56

Manufacturer products Authorised representative products Authorised representative actors View details

PRO-Diary Motion

PRO-Diary

Class IMDR 2017/745On the marketDirect marking

Manufacturer: CamNtech Ltd
Manufacturer SRN: GB-MF-000004683
UDI-DI: B329PDM25
Basic UDI-DI: ++B329PDM01XT
Reference: 05-111
EMDN: Z12040199
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - OTHER
First on market country: Denmark
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 14:53

Manufacturer products Authorised representative products Authorised representative actors View details

MotionWatch 8

MotionWatch

Class IMDR 2017/745On the marketDirect marking

Manufacturer: CamNtech Ltd
Manufacturer SRN: GB-MF-000004683
UDI-DI: B329MW850
Basic UDI-DI: ++B329MTN012J
Reference: 04-111
EMDN: Z12040199
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - OTHER
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 14:53

Manufacturer products Authorised representative products Authorised representative actors View details