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05051716000032

LTK.615

IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: Oxford Immunotec Ltd
Manufacturer SRN: GB-MF-000004429
UDI-DI: 05051716000032
Basic UDI-DI: 5051716LTKCA
Reference: LTK.615
EMDN: W050301020101
EMDN description: SAMPLES ANALYSES, PLASTIC TUBES WITH ADDITIVES
First on market country: Ireland
Authorised representative: Wallac Oy
Last updated: 31.07.2026 08:06

Manufacturer products Authorised representative products Authorised representative actors View details

TENCELL™ Cuvettes

IK702

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: The Binding Site Group Ltd
Manufacturer SRN: UK-MF-000036707
UDI-DI: 05051700020909
Basic UDI-DI: 5051700IK702GP
Reference: IK702
EMDN: W0503010203
EMDN description: SAMPLES ANALYSES, PLASTIC CUVETTES
First on market country: Germany
Authorised representative: The Binding Site Ireland Limited
Last updated: 31.07.2026 08:06

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geneLEAD VIII PCR Reaction Cassette Set

geneLEAD PCR Reaction Cassette Set

IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: Precision System Science Co., Ltd.
Manufacturer SRN: JP-MF-000029061
UDI-DI: 04987869688401
Basic UDI-DI: 4987869gLRreactionP5
Reference: F8840
EMDN: W050301020202
EMDN description: SAMPLES ANALYSES, PLASTIC MICROTUBES WITHOUT ADDITIVES
First on market country: Belgium
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 07:44

Manufacturer products Authorised representative products Authorised representative actors View details

geneLEAD VIII PCR Reagent Cassette Set

geneLEAD PCR Reagent Cassette Set

IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: Precision System Science Co., Ltd.
Manufacturer SRN: JP-MF-000029061
UDI-DI: 04987869688203
Basic UDI-DI: 4987869gLReagentWD
Reference: F8820
EMDN: W050301020202
EMDN description: SAMPLES ANALYSES, PLASTIC MICROTUBES WITHOUT ADDITIVES
First on market country: Luxembourg
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 07:44

Manufacturer products Authorised representative products Authorised representative actors View details

SUC-400A

CUVETTE

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 04987562408931
Basic UDI-DI: 4987562SUC-400A7F
Reference: 064-1481-0
EMDN: W0503010203
EMDN description: SAMPLES ANALYSES, PLASTIC CUVETTES
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 31.07.2026 07:41

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SU-40

REACTION TUBE

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 04987562200139
Basic UDI-DI: 4987562SU-406H
Reference: 904-0721-9
EMDN: W0503010203
EMDN description: SAMPLES ANALYSES, PLASTIC CUVETTES
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 31.07.2026 07:41

Manufacturer products Authorised representative products Authorised representative actors View details

04987562499748

SB Cuvette II

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 04987562499748
Basic UDI-DI: 4987562SBCuvetteIIM4
Reference: CM500820
EMDN: W0503010203
EMDN description: SAMPLES ANALYSES, PLASTIC CUVETTES
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 31.07.2026 07:36

Manufacturer products Authorised representative products Authorised representative actors View details

04987562418664

SB Cuvette

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 04987562418664
Basic UDI-DI: 4987562SBCuvetteB5
Reference: 06410419
EMDN: W0503010203
EMDN description: SAMPLES ANALYSES, PLASTIC CUVETTES
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 31.07.2026 07:34

Manufacturer products Authorised representative products Authorised representative actors View details

Centrifuge Tube (for SPOTCHEM EZ)

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486039129
Basic UDI-DI: 4987486BC0108243GS
Reference: 108243
EMDN: W050301029099
EMDN description: SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 31.07.2026 07:33

Manufacturer products Authorised representative products Authorised representative actors View details

Whole Blood Sample Tube

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486039105
Basic UDI-DI: 4987486BC0108241GN
Reference: 108241
EMDN: W050301029099
EMDN description: SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 31.07.2026 07:33

Manufacturer products Authorised representative products Authorised representative actors View details

Centrifuge Cup (for D-Concept)

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486039099
Basic UDI-DI: 4987486BC0108240GL
Reference: 108240
EMDN: W050301029099
EMDN description: SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 31.07.2026 07:33

Manufacturer products Authorised representative products Authorised representative actors View details

Cuvette (heparin)

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486039075
Basic UDI-DI: 4987486BC0108238GZ
Reference: 108238
EMDN: W050301029099
EMDN description: SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 31.07.2026 07:33

Manufacturer products Authorised representative products Authorised representative actors View details

Reaction Cuvette

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Biolis Medical Corp.
Manufacturer SRN: JP-MF-000025468
UDI-DI: 04580262016866
Basic UDI-DI: 458026201RCRX
Reference: 50-09-0262D
EMDN: W0503010203
EMDN description: SAMPLES ANALYSES, PLASTIC CUVETTES
First on market country: Northern Ireland
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 31.07.2026 06:14

Manufacturer products Authorised representative products Authorised representative actors View details

Cup & Pin pro

200011

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

Manufacturer: Tem Innovations GmbH
Manufacturer SRN: DE-MF-000012176
UDI-DI: 04260160470150
Basic UDI-DI: 4260160470150R7
Reference: 200011
EMDN: W0503010280
EMDN description: SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:39

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TUBO PARA RECOGIDA DE AIRE ESPIRADO BASAL

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: AYALA SAMPLE KITS, S.L.
Manufacturer SRN: ES-MF-000037853
UDI-DI: 08437026387907
Basic UDI-DI: 8437026387CAL0012D
Reference: CAL003.1
EMDN: W0503010101
EMDN description: SAMPLES ANALYSES, GLASS TUBES
First on market country: -
Authorised representative: -
Last updated: 30.07.2026 22:48

Manufacturer products View details

TUBO PARA RECOGIDA DE AIRE ESPIRADO CERO

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: AYALA SAMPLE KITS, S.L.
Manufacturer SRN: ES-MF-000037853
UDI-DI: 08437026387914
Basic UDI-DI: 8437026387CAL0012D
Reference: CAL003.2
EMDN: W0503010101
EMDN description: SAMPLES ANALYSES, GLASS TUBES
First on market country: -
Authorised representative: -
Last updated: 30.07.2026 22:48

Manufacturer products View details

TUBO PARA RECOGIDA DE AIRE ESPIRADO 15

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: AYALA SAMPLE KITS, S.L.
Manufacturer SRN: ES-MF-000037853
UDI-DI: 08437026387921
Basic UDI-DI: 8437026387CAL0012D
Reference: CAL003.3
EMDN: W0503010101
EMDN description: SAMPLES ANALYSES, GLASS TUBES
First on market country: -
Authorised representative: -
Last updated: 30.07.2026 22:48

Manufacturer products View details

TUBO PARA RECOGIDA DE AIRE ESPIRADO 25

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: AYALA SAMPLE KITS, S.L.
Manufacturer SRN: ES-MF-000037853
UDI-DI: 08437026387938
Basic UDI-DI: 8437026387CAL0012D
Reference: CAL003.4
EMDN: W0503010101
EMDN description: SAMPLES ANALYSES, GLASS TUBES
First on market country: -
Authorised representative: -
Last updated: 30.07.2026 22:48

Manufacturer products View details

TUBO PARA RECOGIDA DE AIRE ESPIRADO 30

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: AYALA SAMPLE KITS, S.L.
Manufacturer SRN: ES-MF-000037853
UDI-DI: 08437026387945
Basic UDI-DI: 8437026387CAL0012D
Reference: CAL003.5
EMDN: W0503010101
EMDN description: SAMPLES ANALYSES, GLASS TUBES
First on market country: -
Authorised representative: -
Last updated: 30.07.2026 22:48

Manufacturer products View details

TUBO PARA RECOGIDA DE AIRE ESPIRADO 45

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: AYALA SAMPLE KITS, S.L.
Manufacturer SRN: ES-MF-000037853
UDI-DI: 08437026387952
Basic UDI-DI: 8437026387CAL0012D
Reference: CAL003.6
EMDN: W0503010101
EMDN description: SAMPLES ANALYSES, GLASS TUBES
First on market country: -
Authorised representative: -
Last updated: 30.07.2026 22:48

Manufacturer products View details