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01.08.2026 13:11

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139 device results listed.

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Vanadis Core Reagent Cartridge II

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

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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

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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

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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

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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

-

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

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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

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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

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 P250 DiGeorge

B2

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: MRC Holland B.V.
Manufacturer SRN: NL-MF-000000437
UDI-DI: 08720211482052
Basic UDI-DI: 872021148P2505V
Reference: P250-100R
EMDN: W0106010399
EMDN description: CHROMOSOMAL DISORDERS TESTS - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 01.07.2026 03:43

Manufacturer products View details

SALSA MLPA Probemix P250 DiGeorge

B2

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: MRC Holland B.V.
Manufacturer SRN: NL-MF-000000437
UDI-DI: 08720211482045
Basic UDI-DI: 872021148P2505V
Reference: P250-050R
EMDN: W0106010399
EMDN description: CHROMOSOMAL DISORDERS TESTS - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 01.07.2026 03:43

Manufacturer products View details

SALSA MLPA Probemix P250 DiGeorge

B2

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: MRC Holland B.V.
Manufacturer SRN: NL-MF-000000437
UDI-DI: 08720211482038
Basic UDI-DI: 872021148P2505V
Reference: P250-025R
EMDN: W0106010399
EMDN description: CHROMOSOMAL DISORDERS TESTS - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 01.07.2026 03:43

Manufacturer products View details

Devyser Compact

Devyser Compact

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

Manufacturer: Devyser AB
Manufacturer SRN: SE-MF-000001699
UDI-DI: 07350040631232
Basic UDI-DI: 7350040638A017MN
Reference: 8-R017-100
EMDN: W0106010399
EMDN description: CHROMOSOMAL DISORDERS TESTS - OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 30.06.2026 12:48

Manufacturer products View details

Devyser Compact

Devyser Compact

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

Manufacturer: Devyser AB
Manufacturer SRN: SE-MF-000001699
UDI-DI: 07350040631225
Basic UDI-DI: 7350040638A017MN
Reference: 8-R017-50
EMDN: W0106010399
EMDN description: CHROMOSOMAL DISORDERS TESTS - OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 30.06.2026 12:47

Manufacturer products View details

Devyser Compact

Devyser Compact

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

Manufacturer: Devyser AB
Manufacturer SRN: SE-MF-000001699
UDI-DI: 07350040631218
Basic UDI-DI: 7350040638A017MN
Reference: 8-R017-25
EMDN: W0106010399
EMDN description: CHROMOSOMAL DISORDERS TESTS - OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 30.06.2026 12:47

Manufacturer products View details

Prenatal 13 and 21 Enumeration Probe kit

-

IVD Class CNot specifiedOn the market

Manufacturer: Cytocell Limited
Manufacturer SRN: GB-MF-000016893
UDI-DI: 05055844906051
Basic UDI-DI: 50558449LPA003GL
Reference: CE-LPA 003-S
EMDN: W0106010304
EMDN description: DOWN'S SYNDROME
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 27.06.2026 21:20

Manufacturer products Authorised representative products Authorised representative actors View details

Prenatal 13 and 21 Enumeration Probe kit

-

IVD Class CNot specifiedOn the market

Manufacturer: Cytocell Limited
Manufacturer SRN: GB-MF-000016893
UDI-DI: 05055844927704
Basic UDI-DI: 50558449LPA003GL
Reference: CE-LPA 003
EMDN: W0106010304
EMDN description: DOWN'S SYNDROME
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 27.06.2026 21:20

Manufacturer products Authorised representative products Authorised representative actors View details

Prenatal 13 and 21 Enumeration Probe kit

-

IVD Class CNot specifiedOn the market

Manufacturer: Cytocell Limited
Manufacturer SRN: GB-MF-000016893
UDI-DI: 05055844927711
Basic UDI-DI: 50558449LPA003GL
Reference: CE-LPA 003-S
EMDN: W0106010304
EMDN description: DOWN'S SYNDROME
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 27.06.2026 21:20

Manufacturer products Authorised representative products Authorised representative actors View details

XA AneuScore II

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IVD Class CNot specifiedOn the market

Manufacturer: MetaSystems Probes GmbH
Manufacturer SRN: DE-MF-000006315
UDI-DI: 04251315813427
Basic UDI-DI: 42513158D-5609IVDM9
Reference: D-5609-500-TC
EMDN: W0106010306
EMDN description: MULTIPLE DETECTION OF CHROMOSOMAL DISORDERS TESTS
First on market country: Germany
Authorised representative: -
Last updated: 26.06.2026 23:56

Manufacturer products View details

XA AneuScore III

-

IVD Class CNot specifiedOn the market

Manufacturer: MetaSystems Probes GmbH
Manufacturer SRN: DE-MF-000006315
UDI-DI: 04251315813519
Basic UDI-DI: 42513158D-5613IVDLA
Reference: D-5613-500-TC
EMDN: W0106010306
EMDN description: MULTIPLE DETECTION OF CHROMOSOMAL DISORDERS TESTS
First on market country: Germany
Authorised representative: -
Last updated: 26.06.2026 23:56

Manufacturer products View details