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37 device results listed.

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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

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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

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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

ORAgene Dx

IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: DNA Genotek Inc.
Manufacturer SRN: CA-MF-000003486
UDI-DI: 00627595000026
Basic UDI-DI: 0627595E0500GF
Reference: OGD-500.001
EMDN: W05019002
EMDN description: SALIVA COLLECTION DEVICES
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 22.06.2026 17:06

Manufacturer products Authorised representative products Authorised representative actors View details

ORAgene Dx

IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: DNA Genotek Inc.
Manufacturer SRN: CA-MF-000003486
UDI-DI: 00627595000132
Basic UDI-DI: 0627595E0500GF
Reference: OGD-510
EMDN: W05019002
EMDN description: SALIVA COLLECTION DEVICES
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 22.06.2026 17:06

Manufacturer products Authorised representative products Authorised representative actors View details

ORAgene Dx

IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: DNA Genotek Inc.
Manufacturer SRN: CA-MF-000003486
UDI-DI: 00627595000248
Basic UDI-DI: 0627595E0500GF
Reference: OGD-600
EMDN: W05019002
EMDN description: SALIVA COLLECTION DEVICES
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 22.06.2026 17:06

Manufacturer products Authorised representative products Authorised representative actors View details

ORAgene Dx

IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: DNA Genotek Inc.
Manufacturer SRN: CA-MF-000003486
UDI-DI: 00627595000255
Basic UDI-DI: 0627595E0500GF
Reference: OGD-610
EMDN: W05019002
EMDN description: SALIVA COLLECTION DEVICES
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 22.06.2026 17:06

Manufacturer products Authorised representative products Authorised representative actors View details

ORAgene Dx

IVD Class AIVDR 2017/746On the marketKitSingle use

Manufacturer: DNA Genotek Inc.
Manufacturer SRN: CA-MF-000003486
UDI-DI: 00627595000262
Basic UDI-DI: 0627595A0100EF
Reference: OGD-675
EMDN: A1101
EMDN description: SAMPLE COLLECTION NEUTRAL SWABS
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 22.06.2026 17:06

Manufacturer products Authorised representative products Authorised representative actors View details

ORAcollect Dx

Class IMDR 2017/745No longer on the marketSingle use

Manufacturer: DNA Genotek Inc.
Manufacturer SRN: CA-MF-000003486
UDI-DI: 00627595000316
Basic UDI-DI: 0627595B0200EX
Reference: OCD-100A
EMDN: A1102
EMDN description: SAMPLE COLLECTION SWABS WITH TRANSPORT MEDIUM
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 22.06.2026 17:06

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: 00627595000422
Basic UDI-DI: 0627595H0800HX
Reference: PT-L2P-45
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 22.06.2026 17:06

Manufacturer products Authorised representative products Authorised representative actors View details

OMNIgene Liquefaction Reagent

IVD Class AIVDR 2017/746No longer on the marketReagent

Manufacturer: DNA Genotek Inc.
Manufacturer SRN: CA-MF-000003486
UDI-DI: 00627595000552
Basic UDI-DI: 0627595I0900JF
Reference: OM-LQR-1600
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 22.06.2026 17:06

Manufacturer products Authorised representative products Authorised representative actors View details