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DNA-Col

IVD Class AIVDR 2017/746On the marketDirect markingSingle use

Manufacturer: Labonovum B.V.
Manufacturer SRN: NL-MF-000023312
UDI-DI: 08719324619653
Basic UDI-DI: 11522518719324619653BD
Reference: DNA-Col
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 09.08.2026 02:57

Manufacturer products View details

BINFEI

Air Water Syringe tip

Class IMDR 2017/745On the marketSingle use

Manufacturer: ZHUCHENG BINFEI MEDI-TEK CO.,LTD
Manufacturer SRN: CN-MF-000048252
UDI-DI: 06976262791274
Basic UDI-DI: 697626279BF-AWT1PC
Reference: A00075
EMDN: W05019002
EMDN description: SALIVA COLLECTION DEVICES
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.08.2026 23:07

Manufacturer products Authorised representative products Authorised representative actors View details

Urine & Two Site Swab Sample Collection Kit (Rectal/Throat)

T14000

Class IMDR 2017/745On the marketNo EU rep

Manufacturer: Concepta Diagnostics
Manufacturer SRN: GB-PR-000033063
UDI-DI: 05060757350952
Basic UDI-DI: 506075735T14000SZ
Reference: T14000
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: -
Authorised representative: -
Last updated: 07.08.2026 22:55

Manufacturer products View details

Three Site Swab Sample Collection Kit (Vaginal/Rectal/Throat)

T13000

Class IMDR 2017/745On the marketNo EU rep

Manufacturer: Concepta Diagnostics
Manufacturer SRN: GB-PR-000033063
UDI-DI: 05060757350945
Basic UDI-DI: 506075735T13000SS
Reference: T13000
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: -
Authorised representative: -
Last updated: 07.08.2026 22:55

Manufacturer products View details

Single Site Swab Sample Collection Kit (Vaginal)

T11000

Class IMDR 2017/745On the marketNo EU rep

Manufacturer: Concepta Diagnostics
Manufacturer SRN: GB-PR-000033063
UDI-DI: 05060757350921
Basic UDI-DI: 506075735T11000SC
Reference: T11000
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: -
Authorised representative: -
Last updated: 07.08.2026 22:55

Manufacturer products View details

BINFEI

Class IMDR 2017/745On the marketSingle use

Manufacturer: ZHUCHENG BINFEI MEDI-TEK CO.,LTD
Manufacturer SRN: CN-MF-000048252
UDI-DI: 06976262791281
Basic UDI-DI: 697626279BF-AWT1PC
Reference: A00076
EMDN: W05019002
EMDN description: SALIVA COLLECTION DEVICES
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.08.2026 22:44

Manufacturer products Authorised representative products Authorised representative actors View details

BINFEI

Class IMDR 2017/745On the marketSingle use

Manufacturer: ZHUCHENG BINFEI MEDI-TEK CO.,LTD
Manufacturer SRN: CN-MF-000048252
UDI-DI: 06976262791298
Basic UDI-DI: 697626279BF-AWT1PC
Reference: A00077
EMDN: W05019002
EMDN description: SALIVA COLLECTION DEVICES
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.08.2026 22:44

Manufacturer products Authorised representative products Authorised representative actors View details

BINFEI

Class IMDR 2017/745On the marketSingle use

Manufacturer: ZHUCHENG BINFEI MEDI-TEK CO.,LTD
Manufacturer SRN: CN-MF-000048252
UDI-DI: 06976262791304
Basic UDI-DI: 697626279BF-AWT1PC
Reference: A00078
EMDN: W05019002
EMDN description: SALIVA COLLECTION DEVICES
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.08.2026 22:44

Manufacturer products Authorised representative products Authorised representative actors View details

BINFEI

Class IMDR 2017/745On the marketSingle use

Manufacturer: ZHUCHENG BINFEI MEDI-TEK CO.,LTD
Manufacturer SRN: CN-MF-000048252
UDI-DI: 06976262791311
Basic UDI-DI: 697626279BF-AWT1PC
Reference: A00079
EMDN: W05019002
EMDN description: SALIVA COLLECTION DEVICES
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.08.2026 22:44

Manufacturer products Authorised representative products Authorised representative actors View details

BINFEI

Class IMDR 2017/745On the marketSingle use

Manufacturer: ZHUCHENG BINFEI MEDI-TEK CO.,LTD
Manufacturer SRN: CN-MF-000048252
UDI-DI: 06976262791328
Basic UDI-DI: 697626279BF-AWT1PC
Reference: A00080
EMDN: W05019002
EMDN description: SALIVA COLLECTION DEVICES
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.08.2026 22:44

Manufacturer products Authorised representative products Authorised representative actors View details

BINFEI

Class IMDR 2017/745On the marketSingle use

Manufacturer: ZHUCHENG BINFEI MEDI-TEK CO.,LTD
Manufacturer SRN: CN-MF-000048252
UDI-DI: 06976262791335
Basic UDI-DI: 697626279BF-AWT1PC
Reference: A00081
EMDN: W05019002
EMDN description: SALIVA COLLECTION DEVICES
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.08.2026 22:44

Manufacturer products Authorised representative products Authorised representative actors View details

CentoPGT Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: CENTOGENE GmbH
Manufacturer SRN: DE-MF-000020652
UDI-DI: 04260433590011
Basic UDI-DI: 4260433590000048R
Reference: 230200
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.08.2026 19:31

Manufacturer products View details

Sample Collection Kit

CY-90001T,CY-93050T,CY-93050TS,CY-93050RT,CY-96000T,CY-98000TS,CY-F1-10,CY-90003T-Stuart,CY-90003T-Amies,CY-90003T-Cary Blair,CY-F005-10,CY-93050AM,CY-90002T,CY-95000BM,CY98000T, etc

IVD Class AIVDR 2017/746On the marketKitReagentSingle use

Manufacturer: Huachenyang (Shenzhen) Technology Co., Ltd.
Manufacturer SRN: CN-MF-000020236
UDI-DI: 06974488992345
Basic UDI-DI: 697448899CY-F0/0/5/2/3V7J
Reference: CY-93050R-TS
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Spain
Authorised representative: SUNGO Europe B.V.
Last updated: 07.08.2026 02:44

Manufacturer products Authorised representative products Authorised representative actors View details

Sponge brush

Class INot specifiedOn the marketSingle use

Manufacturer: Hubei V-Medical Products Co.,Ltd.
Manufacturer SRN: CN-MF-000011268
UDI-DI: 16970881930028
Basic UDI-DI: 697023378NSpongeSticksGG
Reference: 370133
EMDN: W05019002
EMDN description: SALIVA COLLECTION DEVICES
First on market country: France
Authorised representative: RAFFIN MEDICAL
Last updated: 06.08.2026 08:24

Manufacturer products Authorised representative products Authorised representative actors View details

Dental sponge

Sterile Sponge Stick 消毒海绵签

Class IMDR 2017/745On the marketDirect markingSingle useSterile

Manufacturer: Hubei V-Medical Products Co.,Ltd.
Manufacturer SRN: CN-MF-000011268
UDI-DI: 26970233788663
Basic UDI-DI: 697023378SpongeStick8D
Reference: ES50STERILE
EMDN: W05019002
EMDN description: SALIVA COLLECTION DEVICES
First on market country: France
Authorised representative: RAFFIN MEDICAL
Last updated: 05.08.2026 16:24

Manufacturer products Authorised representative products Authorised representative actors View details

FOB-TURBI STOOL COLLECTION TUBE

Fecal occult blood Stool Collection Tube

IVD generalIVDR 2017/746On the marketDirect markingProfessional testingSingle use

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673014940
Basic UDI-DI: B-08431673014940
Reference: 1107185
EMDN: W05019001
EMDN description: FAECES COLLECTION DEVICES
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 22:50

Manufacturer products View details

CALPRO-TURBI STOOL COLLECTION TUBE

Calprotectin Stool collection tube

IVD generalIVDR 2017/746On the marketDirect markingProfessional testingSingle use

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673085377
Basic UDI-DI: B-08431673085377
Reference: 1107195
EMDN: W05019001
EMDN description: FAECES COLLECTION DEVICES
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 22:49

Manufacturer products View details

COPRORECOLTOR CU SPATULA PE

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

Manufacturer: SC MEDDO SRL
Manufacturer SRN: RO-MF-000018753
UDI-DI: 05944759042070
Basic UDI-DI: 594475904264252950001009E
Reference: 5285
EMDN: W05019001
EMDN description: FAECES COLLECTION DEVICES
First on market country: Romania
Authorised representative: -
Last updated: 04.08.2026 21:57

Manufacturer products View details

++G226StoolNACPDEVQ6

EZ Collect Stool Nucleic Acid Collection and Preservation Device Dx

IVD Class AIVDR 2017/746On the marketDirect markingNear-patient testingProfessional testingSingle use

Manufacturer: Norgen Biotek Corporation
Manufacturer SRN: CA-MF-000024034
UDI-DI: ++G226StoolNACPDEVQ6
Basic UDI-DI: ++G226StoolNACPDEVQ3
Reference: Dx63730
EMDN: W05019001
EMDN description: FAECES COLLECTION DEVICES
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 04.08.2026 20:52

Manufacturer products Authorised representative products Authorised representative actors View details

++G226490000

Saliva DNA Collection and Preservation Devices Dx

IVD Class AIVDR 2017/746On the marketDirect markingKitNear-patient testingProfessional testingSingle use

Manufacturer: Norgen Biotek Corporation
Manufacturer SRN: CA-MF-000024034
UDI-DI: ++G226490000
Basic UDI-DI: ++G226SalivaDNACPDevJR
Reference: 49000
EMDN: W05019002
EMDN description: SALIVA COLLECTION DEVICES
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details