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224 device results listed.

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Survival Motor Neuron Genes 1, 2 (SMN1, SMN2) Exon Deletion Detection Kit (Fluorescence Quantitative PCR Method)

Survival Motor Neuron Genes 1, 2 (SMN1, SMN2) Exon Deletion Detection Kit (Fluorescence Quantitative PCR Method)

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996004534
Basic UDI-DI: B-06950996004534
Reference: N7001A
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 09:33

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® HLA B-27 Real-Time PCR Kit

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IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213930467
Basic UDI-DI: 89080153043B247NM
Reference: 3B247
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: -
Authorised representative: Wellkang Ltd
Last updated: 27.06.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® HLA B-27 Real-Time PCR Kit

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IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213930474
Basic UDI-DI: 89080153043B247NM
Reference: 3B248
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: -
Authorised representative: Wellkang Ltd
Last updated: 27.06.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® MTHFR Mutation Detection Kit

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IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213930559
Basic UDI-DI: 89080153043B1331KY
Reference: 3B1331
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: -
Authorised representative: Wellkang Ltd
Last updated: 27.06.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® MTHFR Mutation Detection Kit

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IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213930566
Basic UDI-DI: 89080153043B1331KY
Reference: 3B1332
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: -
Authorised representative: Wellkang Ltd
Last updated: 27.06.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

Blueprint Genetics Sanger Platform

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IVD generalNot specifiedOn the marketSingle use

Manufacturer: Blueprint Genetics Oy
Manufacturer SRN: FI-MF-000009837
UDI-DI: 06430079584004
Basic UDI-DI: B-06430079584004
Reference: SAN-400
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 23.06.2026 11:01

Manufacturer products View details

Blueprint Genetics dPCR Platform

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IVD generalNot specifiedOn the marketSingle use

Manufacturer: Blueprint Genetics Oy
Manufacturer SRN: FI-MF-000009837
UDI-DI: 06430079583007
Basic UDI-DI: B-06430079583007
Reference: DPC-300
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 23.06.2026 11:01

Manufacturer products View details

Blueprint Genetics WES Platform – Variant Seq + mtDNA Variant Seq

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IVD generalNot specifiedOn the marketSingle use

Manufacturer: Blueprint Genetics Oy
Manufacturer SRN: FI-MF-000009837
UDI-DI: 06430079581089
Basic UDI-DI: B-06430079581089
Reference: WES-108
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 23.06.2026 11:01

Manufacturer products View details

Blueprint Genetics WES Platform – Variant Seq

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IVD generalNot specifiedOn the marketSingle use

Manufacturer: Blueprint Genetics Oy
Manufacturer SRN: FI-MF-000009837
UDI-DI: 06430079581072
Basic UDI-DI: B-06430079581072
Reference: WES-107
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 23.06.2026 11:01

Manufacturer products View details

Blueprint Genetics WES Platform – Other Family Seq + mtDNA Seq

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IVD generalNot specifiedOn the marketSingle use

Manufacturer: Blueprint Genetics Oy
Manufacturer SRN: FI-MF-000009837
UDI-DI: 06430079581065
Basic UDI-DI: B-06430079581065
Reference: WES-106
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 23.06.2026 11:01

Manufacturer products View details

Blueprint Genetics WES Platform – Family Seq + mtDNA Seq

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IVD generalNot specifiedOn the marketSingle use

Manufacturer: Blueprint Genetics Oy
Manufacturer SRN: FI-MF-000009837
UDI-DI: 06430079581058
Basic UDI-DI: B-06430079581058
Reference: WES-105
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 23.06.2026 11:01

Manufacturer products View details

Blueprint Genetics WES Platform – Proband + mtDNA Seq

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IVD generalNot specifiedOn the marketSingle use

Manufacturer: Blueprint Genetics Oy
Manufacturer SRN: FI-MF-000009837
UDI-DI: 06430079581041
Basic UDI-DI: B-06430079581041
Reference: WES-104
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 23.06.2026 11:01

Manufacturer products View details

Blueprint Genetics WES Platform – Other Family Seq

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IVD generalNot specifiedOn the marketSingle use

Manufacturer: Blueprint Genetics Oy
Manufacturer SRN: FI-MF-000009837
UDI-DI: 06430079581034
Basic UDI-DI: B-06430079581034
Reference: WES-103
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 23.06.2026 11:01

Manufacturer products View details

Blueprint Genetics WES Platform – Family Seq

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IVD generalNot specifiedOn the marketSingle use

Manufacturer: Blueprint Genetics Oy
Manufacturer SRN: FI-MF-000009837
UDI-DI: 06430079581027
Basic UDI-DI: B-06430079581027
Reference: WES-102
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 23.06.2026 11:01

Manufacturer products View details

Blueprint Genetics WES Platform – Proband Seq

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IVD generalNot specifiedOn the marketSingle use

Manufacturer: Blueprint Genetics Oy
Manufacturer SRN: FI-MF-000009837
UDI-DI: 06430079581010
Basic UDI-DI: B-06430079581010
Reference: WES-101
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 23.06.2026 11:01

Manufacturer products View details

Genedrive® MT-RNR1 Negative Control Kit

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IVD generalNot specifiedOn the marketSingle use

Manufacturer: Genedrive Diagnostics Ltd.
Manufacturer SRN: GB-MF-000012810
UDI-DI: 05060654860332
Basic UDI-DI: B-05060654860332
Reference: RNR1-CTRL-03
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Greece
Authorised representative: Advena Limited
Last updated: 20.06.2026 00:43

Manufacturer products Authorised representative products Authorised representative actors View details

Genedrive® MT-RNR1 Positive Control Kit

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IVD generalNot specifiedOn the marketSingle use

Manufacturer: Genedrive Diagnostics Ltd.
Manufacturer SRN: GB-MF-000012810
UDI-DI: 05060654860325
Basic UDI-DI: B-05060654860325
Reference: RNR1-CTRL-02
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Greece
Authorised representative: Advena Limited
Last updated: 20.06.2026 00:43

Manufacturer products Authorised representative products Authorised representative actors View details

Genedrive® MT-RNR1 Control Kit

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IVD generalNot specifiedOn the marketSingle use

Manufacturer: Genedrive Diagnostics Ltd.
Manufacturer SRN: GB-MF-000012810
UDI-DI: 05060654860226
Basic UDI-DI: B-05060654860226
Reference: RNR1-CTRL-01
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Greece
Authorised representative: Advena Limited
Last updated: 20.06.2026 00:43

Manufacturer products Authorised representative products Authorised representative actors View details

Genedrive® MT-RNR1 ID Kit

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IVD generalNot specifiedOn the marketSingle use

Manufacturer: Genedrive Diagnostics Ltd.
Manufacturer SRN: GB-MF-000012810
UDI-DI: 05060654860011
Basic UDI-DI: B-05060654860011
Reference: ID-RNR1-01
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Greece
Authorised representative: Advena Limited
Last updated: 20.06.2026 00:43

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: ImmunoIVD AB
Manufacturer SRN: SE-MF-000034517
UDI-DI: 47350134361173
Basic UDI-DI: 7350134361178Q
Reference: 12-2015-T
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 04:38

Manufacturer products View details