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IDK® Amino Extract (Stool sample preparation system filled with extraction buffer IDK® Amino Extract)

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

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598017009
Basic UDI-DI: 4050598IATUSASXN
Reference: K 7999.RE
EMDN: W05019001
EMDN description: FAECES COLLECTION DEVICES
First on market country: -
Authorised representative: -
Last updated: 31.07.2026 15:25

Manufacturer products View details

ILabU zestaw do samodzielnego pobierania wymazów z nosa, gardła i oka

Class IMDR 2017/745On the market

Manufacturer: IlabU Sp. z o. o.
Manufacturer SRN: PL-PR-000047472
UDI-DI: 05907990579439
Basic UDI-DI: 59079905794smears4C
Reference: ILW003
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: -
Authorised representative: -
Last updated: 31.07.2026 14:35

Manufacturer products View details

ILabU zestaw do samodzielnego pobierania materiału genetycznego: nabłonek policzkowy

Class IMDR 2017/745On the market

Manufacturer: IlabU Sp. z o. o.
Manufacturer SRN: PL-PR-000047472
UDI-DI: 05907990579422
Basic UDI-DI: 59079905794geneticSL
Reference: ILG001
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: -
Authorised representative: -
Last updated: 31.07.2026 14:35

Manufacturer products View details

ILabU zestaw do samodzielnego pobierania próbki: ślina

Class IMDR 2017/745On the market

Manufacturer: IlabU Sp. z o. o.
Manufacturer SRN: PL-PR-000047472
UDI-DI: 05907990579408
Basic UDI-DI: 59079905794saliva29
Reference: ILS004
EMDN: W05019002
EMDN description: SALIVA COLLECTION DEVICES
First on market country: -
Authorised representative: -
Last updated: 31.07.2026 14:35

Manufacturer products View details

BGI

One test per self-sampling kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: 05745000468409
Basic UDI-DI: 5745000468EU01001500019F
Reference: EU0100150001
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:40

Manufacturer products View details

BGI

1 tube/kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: 05745000468379
Basic UDI-DI: 5745000468EU01001000017Q
Reference: EU0100100001
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:40

Manufacturer products View details

BGI

1 pic/set

IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: 05745000468300
Basic UDI-DI: 5745000468MFG010028G7
Reference: MFG010028
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:40

Manufacturer products View details

BGI

one test per collection kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: 05745000468294
Basic UDI-DI: 5745000468MFG010043G3
Reference: MFG010043
EMDN: W05019001
EMDN description: FAECES COLLECTION DEVICES
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:40

Manufacturer products View details

BGI

1 test/kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: 05745000468232
Basic UDI-DI: 5745000468MFG010037G8
Reference: MFG010037
EMDN: W05019001
EMDN description: FAECES COLLECTION DEVICES
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:40

Manufacturer products View details

EasySampler Basic bulk

IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: GP Medical Devices A/S
Manufacturer SRN: DK-MF-000022391
UDI-DI: 05711276131002
Basic UDI-DI: 5711276EasySamplerBASICX7
Reference: 13 10 00
EMDN: W05019001
EMDN description: FAECES COLLECTION DEVICES
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:11

Manufacturer products View details

40ml

ANAPAT Prefilled, contentores pré-cheios com Formol a 10% tamponado

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

Manufacturer: ESTERIPLAS- PRODUTOS PARA A AREA DA SAUDE, LDA
Manufacturer SRN: PT-MF-000033228
UDI-DI: 05608384014870
Basic UDI-DI: 56083842800544Z
Reference: 100500280054
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Portugal
Authorised representative: -
Last updated: 31.07.2026 11:33

Manufacturer products View details

SalivaGene® Swab Comfort

IVD Class AIVDR 2017/746On the marketKitMicrobial substancesReagentSingle use

Manufacturer: ALS Life Sciences Portugal, S.A.
Manufacturer SRN: PT-MF-000034751
UDI-DI: 05600236235235
Basic UDI-DI: 5600236235AA007ED
Reference: 1035231100
EMDN: W05019002
EMDN description: SALIVA COLLECTION DEVICES
First on market country: Portugal
Authorised representative: -
Last updated: 31.07.2026 11:15

Manufacturer products View details

SalivaGene® Collector

IVD Class AIVDR 2017/746On the marketKitMicrobial substancesReagentSingle use

Manufacturer: ALS Life Sciences Portugal, S.A.
Manufacturer SRN: PT-MF-000034751
UDI-DI: 05600236235228
Basic UDI-DI: 5600236235AA006EB
Reference: 1035211200
EMDN: W05019002
EMDN description: SALIVA COLLECTION DEVICES
First on market country: Portugal
Authorised representative: -
Last updated: 31.07.2026 11:15

Manufacturer products View details

Blue Collect

IB_CD01

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

Manufacturer: FertiPro
Manufacturer SRN: BE-MF-000000313
UDI-DI: 05411967003747
Basic UDI-DI: 5411967CD1B3
Reference: IB_CD01
EMDN: W05019002
EMDN description: SALIVA COLLECTION DEVICES
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:52

Manufacturer products View details

HER-KIT003

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

Manufacturer: Hertility Health
Manufacturer SRN: UK-MF-000046710
UDI-DI: 15061090190028
Basic UDI-DI: 506109019HERKIT003YL
Reference: HER-KIT003
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 09:22

Manufacturer products Authorised representative products Authorised representative actors View details

Miscarriage Collection Cradle

DCN001

Class IMDR 2017/745On the marketSingle use

Manufacturer: Dignity Care Network Ltd
Manufacturer SRN: UK-MF-000048837
UDI-DI: 05070003744015
Basic UDI-DI: 50700037440DCNJC
Reference: dcn001
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Ireland
Authorised representative: IMed EUAR Limited
Last updated: 31.07.2026 09:20

Manufacturer products Authorised representative products Authorised representative actors View details

05065024320041

SH24 STI Rectal Sample Collection Kit

IVD Class AIVDR 2017/746On the marketKitSelf testingSingle use

Manufacturer: SH24 Digital Ltd
Manufacturer SRN: UK-MF-000048864
UDI-DI: 05065024320041
Basic UDI-DI: 5065024320RectalMM
Reference: Maroon
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Ireland
Authorised representative: CS Life Sciences Europe Ltd
Last updated: 31.07.2026 09:18

Manufacturer products Authorised representative products Authorised representative actors View details

05065024320010

SH24 STI Throat Sample Collection Kit

IVD Class AIVDR 2017/746On the marketKitSelf testingSingle use

Manufacturer: SH24 Digital Ltd
Manufacturer SRN: UK-MF-000048864
UDI-DI: 05065024320010
Basic UDI-DI: 5065024320ThroatSG
Reference: Charcoal
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Ireland
Authorised representative: CS Life Sciences Europe Ltd
Last updated: 31.07.2026 09:18

Manufacturer products Authorised representative products Authorised representative actors View details

HER-KIT

IVD Class ANot specifiedNot intended for EU marketDirect markingSingle use

Manufacturer: Hertility Health
Manufacturer SRN: UK-MF-000046710
UDI-DI: 15061090190004
Basic UDI-DI: 506109019HERKIT001YG
Reference: HER-KIT001
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 09:12

Manufacturer products Authorised representative products Authorised representative actors View details

05061107470146

Inuvi-006/CE Collection Kit

IVD Class AIVDR 2017/746On the marketDirect markingKitSingle use

Manufacturer: Inuvi Health Limited
Manufacturer SRN: UK-MF-000057167
UDI-DI: 05061107470146
Basic UDI-DI: 5061107470146RH
Reference: Inuvi-006/CE
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 09:09

Manufacturer products Authorised representative products Authorised representative actors View details