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GENEDIAN

IVD Class ANot specifiedNot intended for EU marketSingle use

Manufacturer: Hangzhou DIAN Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000007252
UDI-DI: 06934244550011
Basic UDI-DI: 69342445RA001JL
Reference: P131-01050
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 05:47

Manufacturer products Authorised representative products Authorised representative actors View details

"TRUSSA" fara gel

IVD Class ANot specifiedOn the marketDirect markingSingle use

Manufacturer: PHARMASAVE SRL
Manufacturer SRN: RO-MF-000023044
UDI-DI: 05944759069022
Basic UDI-DI: 5944759069COPRTRUSSAGELKH
Reference: 5948931002609x
EMDN: W05019001
EMDN description: FAECES COLLECTION DEVICES
First on market country: Romania
Authorised representative: -
Last updated: 05.07.2026 07:49

Manufacturer products View details

SCU Wide Cap Sampler

Safety SubCulture Unit

IVD Class AIVDR 2017/746Not intended for EU marketSingle useSterile

Manufacturer: ITL Asia Pacific Sdn. Bhd.
Manufacturer SRN: MY-MF-000001570
UDI-DI: 09555240404985
Basic UDI-DI: 955524040SCUSJY
Reference: A100723
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 04.07.2026 00:19

Manufacturer products Authorised representative products Authorised representative actors View details

SampLok® Sampling Kit 16mL

SampLok Sampling Kit

IVD Class AIVDR 2017/746On the marketSingle useSterile

Manufacturer: ITL Asia Pacific Sdn. Bhd.
Manufacturer SRN: MY-MF-000001570
UDI-DI: 09555240400536
Basic UDI-DI: 955524040SSKSLJ
Reference: A100740
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: France
Authorised representative: Emergo Europe B.V.
Last updated: 04.07.2026 00:19

Manufacturer products Authorised representative products Authorised representative actors View details

BiomeCollect

IVD Class ANot specifiedOn the marketDirect markingSingle use

Manufacturer: Biome Diagnostics GmbH
Manufacturer SRN: AT-MF-000052920
UDI-DI: 09120144350012
Basic UDI-DI: 912014435COLLECTA9
Reference: BiomeCollect
EMDN: W05019001
EMDN description: FAECES COLLECTION DEVICES
First on market country: Austria
Authorised representative: -
Last updated: 04.07.2026 00:03

Manufacturer products View details

Probennahme-Set für Stuhlproben mit Laboranalyse (OC-Sensor)

Class IMDR 2017/745On the market

Manufacturer: DoctorBox Service GmbH
Manufacturer SRN: DE-PR-000032893
UDI-DI: 112093506912
Basic UDI-DI: PP11344IFBT71
Reference: 112093506912
EMDN: W05019001
EMDN description: FAECES COLLECTION DEVICES
First on market country: -
Authorised representative: -
Last updated: 03.07.2026 22:43

Manufacturer products View details

SynSwab Collector

08720299830530

IVD Class AIVDR 2017/746On the marketDirect markingSingle use

Manufacturer: MolGen BV
Manufacturer SRN: NL-MF-000022886
UDI-DI: 08720299830530
Basic UDI-DI: 87202998305RCPT7B
Reference: MG0000450
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 03.07.2026 19:53

Manufacturer products View details

MolGen Saliva Collector

08720299830509

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

Manufacturer: MolGen BV
Manufacturer SRN: NL-MF-000022886
UDI-DI: 08720299830509
Basic UDI-DI: 87202998305RCPTSAL7P
Reference: MG0000044
EMDN: W05019002
EMDN description: SALIVA COLLECTION DEVICES
First on market country: Netherlands
Authorised representative: -
Last updated: 03.07.2026 19:53

Manufacturer products View details

CFΔ COLLECTION SYSTEM

UTS022

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

Manufacturer: UTSAT SAĞLIK TEKNOLOJİLERİ SANAYİ TİCARET LİMİTED ŞİRKETİ
Manufacturer SRN: TR-MF-000016643
UDI-DI: 08699226000257
Basic UDI-DI: 86992260UTS0223J
Reference: UTS022
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 19:09

Manufacturer products View details

CFΔ Collection System

UTS021

IVD Class AIVDR 2017/746On the marketDirect markingSingle use

Manufacturer: UTSAT SAĞLIK TEKNOLOJİLERİ SANAYİ TİCARET LİMİTED ŞİRKETİ
Manufacturer SRN: TR-MF-000016643
UDI-DI: 08699226000110
Basic UDI-DI: 86992260UTS0213G
Reference: UTS021
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 19:09

Manufacturer products View details

Faeces Container 25-30mL, Individually Packaged

FAECES CONTAINERS

IVD Class AIVDR 2017/746On the marketSingle useSterile

Manufacturer: Medikal Olusum Sanayi ve Ticaret Limited Sirketi
Manufacturer SRN: TR-MF-000026274
UDI-DI: 08684341089058
Basic UDI-DI: 8684341089BPGKCZ
Reference: BPGK00004
EMDN: W05019001
EMDN description: FAECES COLLECTION DEVICES
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 18:32

Manufacturer products View details

LABOSEL

Faecal Specimen Container

IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: OLGUN MEDİKAL İNŞAAT VE TİCARET LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047327
UDI-DI: 08684041381636
Basic UDI-DI: 86840413835561XY
Reference: LB.01.024
EMDN: W05019001
EMDN description: FAECES COLLECTION DEVICES
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 18:16

Manufacturer products View details

TÜSEB DiaVTM

TÜSEB DiaVTM Viral Transport Medium

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: SBT Sağlık Bilim ve Teknolojileri A.Ş.
Manufacturer SRN: TR-MF-000036941
UDI-DI: 08683561193033
Basic UDI-DI: 8683561193VTMME
Reference: SBTVTM2022-100
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 18:14

Manufacturer products View details

Specimen Container 25-30mL, Individually Packaged

SPECIMEN CONTAINER

IVD Class AIVDR 2017/746On the marketSterile

Manufacturer: Medikal Olusum Sanayi ve Ticaret Limited Sirketi
Manufacturer SRN: TR-MF-000026274
UDI-DI: 08683052629904
Basic UDI-DI: 8683052629BPSPCT
Reference: BPSP00021
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 18:10

Manufacturer products View details

NUCLISWAB

NUCLEIC ACID SAMPLING AND TRANSPORT KIT

IVD Class AIVDR 2017/746On the marketKitSingle use

Manufacturer: Innovative Biotechnology Organization Trade Limited Company
Manufacturer SRN: TR-MF-000037634
UDI-DI: 08681677201888
Basic UDI-DI: 86816772SWPAJ
Reference: TS060
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 17:33

Manufacturer products View details

Easy 2 Stool Extraction Device

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696305581
Basic UDI-DI: 859569630075QY
Reference: 80-ESED2-100
EMDN: W05019001
EMDN description: FAECES COLLECTION DEVICES
First on market country: Czechia
Authorised representative: -
Last updated: 03.07.2026 17:04

Manufacturer products View details

08594210472068

Corotest VTM (virological transport medium)

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

Manufacturer: LabMediaServis s.r.o.
Manufacturer SRN: CZ-MF-000045078
UDI-DI: 08594210472068
Basic UDI-DI: 8594210470000000VTMMM
Reference: VTM
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Czechia
Authorised representative: -
Last updated: 03.07.2026 16:48

Manufacturer products View details

08594210470880

Corotest IVTM (inhibitive virological transport medium)

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

Manufacturer: LabMediaServis s.r.o.
Manufacturer SRN: CZ-MF-000045078
UDI-DI: 08594210470880
Basic UDI-DI: 859421047000000IVTMSV
Reference: IVTM
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Czechia
Authorised representative: -
Last updated: 03.07.2026 16:47

Manufacturer products View details

iSWAB

IRC-T-EL-R

IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: Mawi DNA Technologies, LLC
Manufacturer SRN: US-MF-000023207
UDI-DI: 20850040712258
Basic UDI-DI: 85004071220850040712258RC
Reference: IRC-T-EL-R
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Northern Ireland
Authorised representative: CEpartner4U
Last updated: 03.07.2026 15:28

Manufacturer products Authorised representative products Authorised representative actors View details

TMH-01 SISTEMA DE RECOLECCIÓN DE MATERIAL FECAL PARA ANÁLISIS CLÍNICO

TMH-01

IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: MIRNAX BIOSENS S.L.
Manufacturer SRN: ES-MF-000051105
UDI-DI: 08447673000005
Basic UDI-DI: 8447673TMH016J
Reference: TMH-01
EMDN: W05019001
EMDN description: FAECES COLLECTION DEVICES
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 15:28

Manufacturer products View details