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16933298295005

I-2

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: Jiangsu Suyun Medical Materials Co., Ltd.
Manufacturer SRN: CN-MF-000021132
UDI-DI: 16933298295005
Basic UDI-DI: 69332982073VV
Reference: NA
EMDN: A1101
EMDN description: SAMPLE COLLECTION NEUTRAL SWABS
First on market country: Bulgaria
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 05:31

Manufacturer products Authorised representative products Authorised representative actors View details

eSwab

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Copan Italia S.P.A.
Manufacturer SRN: IT-MF-000022535
UDI-DI: 18053326011891
Basic UDI-DI: 80533260BD005P2M002FB
Reference: 4E173S01.TR
EMDN: A1102
EMDN description: SAMPLE COLLECTION SWABS WITH TRANSPORT MEDIUM
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 12:04

Manufacturer products View details

CITOSWAB

Nylon

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: CITOTEST LABWARE MANUFACTURING CO.,LTD
Manufacturer SRN: CN-MF-000017214
UDI-DI: 06942826221815
Basic UDI-DI: 697079159SWA1000B00RLK
Reference: 2123-1106
EMDN: A1101
EMDN description: SAMPLE COLLECTION NEUTRAL SWABS
First on market country: Austria
Authorised representative: Wellkang Ltd
Last updated: 16.07.2026 10:57

Manufacturer products Authorised representative products Authorised representative actors View details

16933298294091

I-2

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: Jiangsu Suyun Medical Materials Co., Ltd.
Manufacturer SRN: CN-MF-000021132
UDI-DI: 16933298294091
Basic UDI-DI: 69332982073VV
Reference: NA
EMDN: A1101
EMDN description: SAMPLE COLLECTION NEUTRAL SWABS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 10:34

Manufacturer products Authorised representative products Authorised representative actors View details

RealTime

Specimen Collection Swab

Class IMDR 2017/745Not intended for EU marketSingle useSterile

Manufacturer: Abbott Molecular Inc.
Manufacturer SRN: US-MF-000017776
UDI-DI: 00884999051737
Basic UDI-DI: 0884999YZR0920JX
Reference: 09R20-001
EMDN: A1101
EMDN description: SAMPLE COLLECTION NEUTRAL SWABS
First on market country: -
Authorised representative: Abbott B.V.
Last updated: 16.07.2026 07:24

Manufacturer products Authorised representative products Authorised representative actors View details

Xpert®

Xpert® Swab Specimen Collection Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: Cepheid
Manufacturer SRN: US-MF-000010979
UDI-DI: 07332940007003
Basic UDI-DI: 081164701-SWAB/G-43
Reference: SWAB/G-50
EMDN: A1102
EMDN description: SAMPLE COLLECTION SWABS WITH TRANSPORT MEDIUM
First on market country: Netherlands
Authorised representative: Cepheid AB
Last updated: 16.07.2026 04:13

Manufacturer products Authorised representative products Authorised representative actors View details

Xpert®

Xpert® Nasal Sample Collection Kit

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

Manufacturer: Cepheid
Manufacturer SRN: US-MF-000010979
UDI-DI: 07332940006457
Basic UDI-DI: 081164701-SWAB/F-3Y
Reference: SWAB/F-100
EMDN: A1102
EMDN description: SAMPLE COLLECTION SWABS WITH TRANSPORT MEDIUM
First on market country: Netherlands
Authorised representative: Cepheid Europe S.A.S.
Last updated: 16.07.2026 04:13

Manufacturer products Authorised representative products Authorised representative actors View details

Xpert®

Xpert® Nasopharyngeal Sample Collection Kit

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

Manufacturer: Cepheid
Manufacturer SRN: US-MF-000010979
UDI-DI: 07332940002565
Basic UDI-DI: 081164701-SWAB/B-3L
Reference: SWAB/B-100
EMDN: A1102
EMDN description: SAMPLE COLLECTION SWABS WITH TRANSPORT MEDIUM
First on market country: Netherlands
Authorised representative: Cepheid Europe S.A.S.
Last updated: 16.07.2026 04:13

Manufacturer products Authorised representative products Authorised representative actors View details

Xpert®

Xpert® Vaginal/Endocervical Specimen Collection Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: Cepheid
Manufacturer SRN: US-MF-000010979
UDI-DI: 07332940002558
Basic UDI-DI: 081164701-SWAB/A-3H
Reference: SWAB/A-50
EMDN: A1102
EMDN description: SAMPLE COLLECTION SWABS WITH TRANSPORT MEDIUM
First on market country: Netherlands
Authorised representative: Cepheid AB
Last updated: 16.07.2026 04:13

Manufacturer products Authorised representative products Authorised representative actors View details

06975226960008

PY1\PY2\PY3\PY4\PY5\PY6\PF3\PF4

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: Anji Huayong Biological Technology Co., Ltd.
Manufacturer SRN: CN-MF-000022477
UDI-DI: 06975226960008
Basic UDI-DI: 06975226960091WE
Reference: MDR
EMDN: A1101
EMDN description: SAMPLE COLLECTION NEUTRAL SWABS
First on market country: Austria
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 16.07.2026 01:15

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

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

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

00609576900020

Collection & Transport System, Non-Sterile

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

Manufacturer: Puritan Medical Products Company
Manufacturer SRN: US-MF-000007051
UDI-DI: 00609576900020
Basic UDI-DI: 0609576TMNSCD3L
Reference: UT-106
EMDN: A1102
EMDN description: SAMPLE COLLECTION SWABS WITH TRANSPORT MEDIUM
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 00:53

Manufacturer products Authorised representative products Authorised representative actors View details

00609576330896

Absorbent Tipped Applicators, Non-Sterile

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: Puritan Medical Products Company
Manufacturer SRN: US-MF-000007051
UDI-DI: 00609576330896
Basic UDI-DI: 0609576ATANSU9
Reference: 25-3806-H
EMDN: A1101
EMDN description: SAMPLE COLLECTION NEUTRAL SWABS
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 00:53

Manufacturer products Authorised representative products Authorised representative actors View details

00609576010019

Absorbent Tipped Applicators, Sterile

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: Puritan Medical Products Company
Manufacturer SRN: US-MF-000007051
UDI-DI: 00609576010019
Basic UDI-DI: 0609576ATAS29
Reference: 25-3320-H
EMDN: A1101
EMDN description: SAMPLE COLLECTION NEUTRAL SWABS
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 00:53

Manufacturer products Authorised representative products Authorised representative actors View details

Quantisal Oral Fluid Collection Device

QSI-0025NINT

Class IMDR 2017/745On the marketSingle use

Manufacturer: Immunalysis Corporation
Manufacturer SRN: US-MF-000001555
UDI-DI: 00840937112311
Basic UDI-DI: 00840937QUA0003AH
Reference: QSI-0025NINT
EMDN: A1102
EMDN description: SAMPLE COLLECTION SWABS WITH TRANSPORT MEDIUM
First on market country: Ireland
Authorised representative: Abbott Rapid Dx International Limited
Last updated: 15.07.2026 22:25

Manufacturer products Authorised representative products Authorised representative actors View details

Quantisal II Oral Fluid Collection Device

QSII-0025INT

Class IMDR 2017/745On the marketSingle use

Manufacturer: Immunalysis Corporation
Manufacturer SRN: US-MF-000001555
UDI-DI: 00840937103258
Basic UDI-DI: 00840937QUA0002AF
Reference: QSII-0025INT
EMDN: A1102
EMDN description: SAMPLE COLLECTION SWABS WITH TRANSPORT MEDIUM
First on market country: Ireland
Authorised representative: Abbott Rapid Dx International Limited
Last updated: 15.07.2026 22:25

Manufacturer products Authorised representative products Authorised representative actors View details

++G546VANDL0025A6

Non woven swab

Class IMDR 2017/745On the marketSingle use

Manufacturer: VANDL BIOTECHNOLOGY INC
Manufacturer SRN: CN-MF-000037509
UDI-DI: ++G546VANDL0025A6
Basic UDI-DI: ++G54600252E
Reference: 0025
EMDN: A1101
EMDN description: SAMPLE COLLECTION NEUTRAL SWABS
First on market country: Greece
Authorised representative: MB Global Service B.V.
Last updated: 15.07.2026 21:20

Manufacturer products Authorised representative products Authorised representative actors View details