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Microbiome Home Sample Collection Kit

IVD Class AIVDR 2017/746On the marketNo EU repKitSingle use

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273219876
Basic UDI-DI: 50552732AHMSCKT057K9
Reference: SCK10665
EMDN: W05019001
EMDN description: FAECES COLLECTION DEVICES
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:13

Manufacturer products View details

Home Saliva Collection Kit

IVD Class AIVDR 2017/746On the marketNo EU repKitSingle use

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273219333
Basic UDI-DI: 50552732AHSSCKT056NR
Reference: SCK10654
EMDN: W05019002
EMDN description: SALIVA COLLECTION DEVICES
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:13

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CONFIDANTE

IVD Class AIVDR 2017/746On the marketNo EU repKitSingle use

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273217919
Basic UDI-DI: 50552732ACONSTI017LZ
Reference: EV3879
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:13

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EXTEL HEMO・AUTO MC Collection Picker

IVD Class AIVDR 2017/746On the marketAnimal tissuesKitProfessional testing

Manufacturer: Canon Medical Diagnostics Corporation
Manufacturer SRN: JP-MF-000020364
UDI-DI: 04987295636311
Basic UDI-DI: 4987295BU003ZV
Reference: 63631
EMDN: W05019001
EMDN description: FAECES COLLECTION DEVICES
First on market country: Spain
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 07:32

Manufacturer products Authorised representative products Authorised representative actors View details

Specimen Collection Container A

IVD Class AIVDR 2017/746On the marketAnimal tissuesReagentSingle use

Manufacturer: Alfresa Pharma Corporation
Manufacturer SRN: JP-MF-000008778
UDI-DI: 04987274058608
Basic UDI-DI: 4987274W05019001SCC007Z
Reference: 905860
EMDN: W05019001
EMDN description: FAECES COLLECTION DEVICES
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 07:31

Manufacturer products Authorised representative products Authorised representative actors View details

OC-Light™ S FIT Sampling Bottles

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testing

Manufacturer: EIKEN CHEMICAL CO., LTD.
Manufacturer SRN: JP-MF-000018097
UDI-DI: 04987026212289
Basic UDI-DI: 4987026TD-OCLBYU
Reference: V-PH82
EMDN: W05019001
EMDN description: FAECES COLLECTION DEVICES
First on market country: Italy
Authorised representative: Advena Limited
Last updated: 31.07.2026 07:31

Manufacturer products Authorised representative products Authorised representative actors View details

OC-Auto Sampling Bottle 3 (VCPZ25)

OC-Auto Sampling Bottle 3

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testing

Manufacturer: EIKEN CHEMICAL CO., LTD.
Manufacturer SRN: JP-MF-000018097
UDI-DI: 04987026130088
Basic UDI-DI: 4987026TD-OCSBZH
Reference: V-PZ25
EMDN: W05019001
EMDN description: FAECES COLLECTION DEVICES
First on market country: Belgium
Authorised representative: Advena Limited
Last updated: 31.07.2026 07:31

Manufacturer products Authorised representative products Authorised representative actors View details

TimeTeller® – Your Circadian Rhythm

Saliva sampling and submission kit

IVD Class AIVDR 2017/746On the marketDirect markingKitReagentSingle use

Manufacturer: TimeTeller GmbH
Manufacturer SRN: DE-MF-000044816
UDI-DI: 04262502760004
Basic UDI-DI: 426250276circadian-kit6H
Reference: 4262502760004
EMDN: W05019002
EMDN description: SALIVA COLLECTION DEVICES
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:41

Manufacturer products View details

Novo Saliva Kit

VSKP

IVD Class AIVDR 2017/746On the marketHuman tissuesKitMicrobial substancesNear-patient testingProfessional testingSelf testingSingle use

Manufacturer: Novogenia GmbH
Manufacturer SRN: AT-MF-000038731
UDI-DI: 04262456220012
Basic UDI-DI: 426245622VSKPEG
Reference: VSKP
EMDN: W05019002
EMDN description: SALIVA COLLECTION DEVICES
First on market country: Austria
Authorised representative: -
Last updated: 31.07.2026 05:37

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Probenentnahmeset Stuhl

Probenentnahmeset - Stuhl

Class IMDR 2017/745On the market

Manufacturer: vivatura GmbH
Manufacturer SRN: DE-PR-000042971
UDI-DI: 04262450880403
Basic UDI-DI: 426245088stuhl8Q
Reference: stuhl
EMDN: W05019001
EMDN description: FAECES COLLECTION DEVICES
First on market country: -
Authorised representative: -
Last updated: 31.07.2026 05:37

Manufacturer products View details

Probenentnahmeset Urin und Trockenblutkarte

Probenentnahmeset - Urin und Trockenblutkarte

Class IIaMDR 2017/745On the market

Manufacturer: vivatura GmbH
Manufacturer SRN: DE-PR-000042971
UDI-DI: 04262450880366
Basic UDI-DI: 426245088urindbsCK
Reference: urindbs
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: -
Authorised representative: -
Last updated: 31.07.2026 05:37

Manufacturer products View details

04262401270055

Vaginal Swab Sample Collection Kit

Class IMDR 2017/745On the market

Manufacturer: DasLab GmbH
Manufacturer SRN: DE-PR-000025410
UDI-DI: 04262401270055
Basic UDI-DI: 426240127PP-SWA-VA-HPVZT
Reference: 4262401270055
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: -
Authorised representative: -
Last updated: 31.07.2026 05:31

Manufacturer products View details

04262401270031

Stool Sample Collection Kit

Class IMDR 2017/745On the market

Manufacturer: DasLab GmbH
Manufacturer SRN: DE-PR-000025410
UDI-DI: 04262401270031
Basic UDI-DI: 426240127PP-STO-BLXQ
Reference: 4262401270031
EMDN: W05019001
EMDN description: FAECES COLLECTION DEVICES
First on market country: -
Authorised representative: -
Last updated: 31.07.2026 05:31

Manufacturer products View details

SAMPLING.pro

4600

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

Manufacturer: BIOMES NGS GmbH
Manufacturer SRN: DE-MF-000042230
UDI-DI: 04260582940019
Basic UDI-DI: 4260582944600YH
Reference: 4600
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 02:11

Manufacturer products View details

CentoPGT Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: CENTOGENE GmbH
Manufacturer SRN: DE-MF-000020652
UDI-DI: 04260433590028
Basic UDI-DI: 4260433590000048R
Reference: 230214
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 31.07.2026 01:59

Manufacturer products View details

ScheBo Quick-Prep

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: ScheBo Biotech AG
Manufacturer SRN: DE-MF-000024072
UDI-DI: 04260152082811
Basic UDI-DI: 4260152082815A
Reference: 28-Quick-L
EMDN: W05019001
EMDN description: FAECES COLLECTION DEVICES
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:31

Manufacturer products View details

ScheBo Master Quick-Prep

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

Manufacturer: ScheBo Biotech AG
Manufacturer SRN: DE-MF-000024072
UDI-DI: 04260152082804
Basic UDI-DI: 42601520828058
Reference: 28-Quick
EMDN: W05019001
EMDN description: FAECES COLLECTION DEVICES
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:31

Manufacturer products View details

04260152082613

ScheBo Hb Smart Patient Set

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

Manufacturer: ScheBo Biotech AG
Manufacturer SRN: DE-MF-000024072
UDI-DI: 04260152082613
Basic UDI-DI: 42601520826154
Reference: 26-P
EMDN: W05019001
EMDN description: FAECES COLLECTION DEVICES
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:31

Manufacturer products View details

ScheBo Quick-Prep XL

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: ScheBo Biotech AG
Manufacturer SRN: DE-MF-000024072
UDI-DI: 04260152081609
Basic UDI-DI: 4260152081604V
Reference: 16
EMDN: W05019001
EMDN description: FAECES COLLECTION DEVICES
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:31

Manufacturer products View details

cerascreen® Darmflora Test

Probenahme- und Einsende-Kit Stuhl

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

Manufacturer: Cerascreen GmbH
Manufacturer SRN: DE-MF-000017602
UDI-DI: 04251620704427
Basic UDI-DI: 42516207004JV
Reference: 99010292
EMDN: W05019001
EMDN description: FAECES COLLECTION DEVICES
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:02

Manufacturer products View details