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830 device results listed.

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560 Sizer Orange

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

Manufacturer: Devyser AB
Manufacturer SRN: SE-MF-000001699
UDI-DI: 07350040632079
Basic UDI-DI: 7350040638R402RL
Reference: 8-R402
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:51

Manufacturer products View details

DEV-5 Dye Set, MultiCap

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

Manufacturer: Devyser AB
Manufacturer SRN: SE-MF-000001699
UDI-DI: 07350040632062
Basic UDI-DI: 7350040638R401RJ
Reference: 8-R401
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:51

Manufacturer products View details

Devyser Library Clean

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

Manufacturer: Devyser AB
Manufacturer SRN: SE-MF-000001699
UDI-DI: 07350040632055
Basic UDI-DI: 7350040638R204RE
Reference: 8-R204
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:50

Manufacturer products View details

Devyser Index Plate LB-A

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

Manufacturer: Devyser AB
Manufacturer SRN: SE-MF-000001699
UDI-DI: 07350040632048
Basic UDI-DI: 7350040638R202RA
Reference: 8-R202
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:50

Manufacturer products View details

NIFTY®

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: 05744003510313
Basic UDI-DI: 574400351MFG03011085
Reference: MFG030112
EMDN: W0106010306
EMDN description: MULTIPLE DETECTION OF CHROMOSOMAL DISORDERS TESTS
First on market country: -
Safety summary (SSCP/SSP): BGIEU-STP-CE-116-011 · Rev. 3
Authorised representative: -
Last updated: 02.07.2026 22:44

Manufacturer products Open in EUDAMED View details

06974776970000

160 tests/kit

IVD Class AIVDR 2017/746On the marketKit

Manufacturer: CapitalBio Genomics Co.,Ltd.
Manufacturer SRN: CN-MF-000027716
UDI-DI: 06974776970000
Basic UDI-DI: 697477697FAL01RS
Reference: 160 tests/kit
EMDN: W0106010399
EMDN description: CHROMOSOMAL DISORDERS TESTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 17:27

Manufacturer products Authorised representative products Authorised representative actors View details

Vanadis Core Reagent Cartridge II

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Wallac Oy
Manufacturer SRN: FI-MF-000022620
UDI-DI: 06438147382507
Basic UDI-DI: 6438147Vanadis_RC2XU
Reference: 3222-002B
EMDN: W0106010399
EMDN description: CHROMOSOMAL DISORDERS TESTS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:04

Manufacturer products View details

Eonis SCID-SMA kit

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Wallac Oy
Manufacturer SRN: FI-MF-000022620
UDI-DI: 06438147377725
Basic UDI-DI: 6438147Eonis_SCID-SMA62
Reference: 3241-0010
EMDN: W0106010299
EMDN description: POLYGENETIC DISORDERS TESTS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:04

Manufacturer products View details

NIFTY®

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: 05744003510245
Basic UDI-DI: 574400351MFG03011085
Reference: MFG030110
EMDN: W0106010306
EMDN description: MULTIPLE DETECTION OF CHROMOSOMAL DISORDERS TESTS
First on market country: -
Safety summary (SSCP/SSP): BGIEU-STP-CE-116-011 · Rev. 3
Authorised representative: -
Last updated: 02.07.2026 06:32

Manufacturer products Open in EUDAMED View details

NIFTY®

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: 05744003510252
Basic UDI-DI: 574400351MFG03011085
Reference: MFG030110
EMDN: W0106010306
EMDN description: MULTIPLE DETECTION OF CHROMOSOMAL DISORDERS TESTS
First on market country: -
Safety summary (SSCP/SSP): BGIEU-STP-CE-116-011 · Rev. 3
Authorised representative: -
Last updated: 02.07.2026 06:32

Manufacturer products Open in EUDAMED View details

NIFTY®

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: 05744003510269
Basic UDI-DI: 574400351MFG03011085
Reference: MFG030111
EMDN: W0106010306
EMDN description: MULTIPLE DETECTION OF CHROMOSOMAL DISORDERS TESTS
First on market country: -
Safety summary (SSCP/SSP): BGIEU-STP-CE-116-011 · Rev. 3
Authorised representative: -
Last updated: 02.07.2026 06:32

Manufacturer products Open in EUDAMED View details

NIFTY®

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: 05744003510276
Basic UDI-DI: 574400351MFG03011085
Reference: MFG030111
EMDN: W0106010306
EMDN description: MULTIPLE DETECTION OF CHROMOSOMAL DISORDERS TESTS
First on market country: -
Safety summary (SSCP/SSP): BGIEU-STP-CE-116-011 · Rev. 3
Authorised representative: -
Last updated: 02.07.2026 06:32

Manufacturer products Open in EUDAMED View details

NIFTY®

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: 05744003510283
Basic UDI-DI: 574400351MFG03011085
Reference: MFG030111
EMDN: W0106010306
EMDN description: MULTIPLE DETECTION OF CHROMOSOMAL DISORDERS TESTS
First on market country: -
Safety summary (SSCP/SSP): BGIEU-STP-CE-116-011 · Rev. 3
Authorised representative: -
Last updated: 02.07.2026 06:32

Manufacturer products Open in EUDAMED View details

NIFTY®

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: 05744003510290
Basic UDI-DI: 574400351MFG03011085
Reference: MFG030112
EMDN: W0106010306
EMDN description: MULTIPLE DETECTION OF CHROMOSOMAL DISORDERS TESTS
First on market country: -
Safety summary (SSCP/SSP): BGIEU-STP-CE-116-011 · Rev. 3
Authorised representative: -
Last updated: 02.07.2026 06:32

Manufacturer products Open in EUDAMED View details

NIFTY®

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: 05744003510306
Basic UDI-DI: 574400351MFG03011085
Reference: MFG030112
EMDN: W0106010306
EMDN description: MULTIPLE DETECTION OF CHROMOSOMAL DISORDERS TESTS
First on market country: -
Safety summary (SSCP/SSP): BGIEU-STP-CE-116-011 · Rev. 3
Authorised representative: -
Last updated: 02.07.2026 06:32

Manufacturer products Open in EUDAMED View details

APO-Easy® genotyping kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Firalis SA
Manufacturer SRN: FR-MF-000035853
UDI-DI: 37700265470078
Basic UDI-DI: 3770026547PCRNEUROL001CR4
Reference: FLS-OE-02
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 01.07.2026 16:10

Manufacturer products View details

HLAB27GUARD

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: APPOLON BIOTECK
Manufacturer SRN: FR-MF-000022234
UDI-DI: 03760322820119
Basic UDI-DI: 376032282CGENHLAB27J6
Reference: AB0022
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 15:25

Manufacturer products View details

ThromboGUARD FII FV

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: APPOLON BIOTECK
Manufacturer SRN: FR-MF-000022234
UDI-DI: 03760322820102
Basic UDI-DI: 376032282CGENF2F5FW
Reference: AB0023
EMDN: W0106010115
EMDN description: COMBINED FACTOR II / FACTOR V LEIDEN
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 15:25

Manufacturer products View details

iSAFETM NIPT Kit with 6-color naica system:

Ref: NIPT-100AS

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Atila Biosystems Inc.
Manufacturer SRN: US-MF-000023011
UDI-DI: 01240000008708
Basic UDI-DI: 12400000087NIPTA6S
Reference: NIPT-100AS
EMDN: W0106010399
EMDN description: CHROMOSOMAL DISORDERS TESTS - OTHER
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 01.07.2026 11:16

Manufacturer products Authorised representative products Authorised representative actors View details

SALSA MLPA Probemix P044 NF2

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: MRC Holland B.V.
Manufacturer SRN: NL-MF-000000437
UDI-DI: 08720211482748
Basic UDI-DI: 872021148P0445Q
Reference: P044-100R
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 01.07.2026 03:44

Manufacturer products View details