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769 device results listed.

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DEVYSER CFTR

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

Manufacturer: Devyser AB
Manufacturer SRN: SE-MF-000001699
UDI-DI: 07350040632161
Basic UDI-DI: 7350040638R101R3
Reference: 8-R101-24
EMDN: W0106010101
EMDN description: CYSTIC FIBROSIS
First on market country: Sweden
Authorised representative: -
Last updated: 30.06.2026 12:48

Manufacturer products View details

One Lambda Devyser Chimerism (48 test)

One Lambda Devyser Chimerism

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Devyser AB
Manufacturer SRN: SE-MF-000001699
UDI-DI: 07350040631911
Basic UDI-DI: 7350040638R107RF
Reference: 8-R107-48
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 30.06.2026 12:48

Manufacturer products View details

One Lambda Devyser Chimerism (24 test)

One Lambda Devyser Chimerism

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Devyser AB
Manufacturer SRN: SE-MF-000001699
UDI-DI: 07350040631904
Basic UDI-DI: 7350040638R107RF
Reference: 8-R107-24
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 30.06.2026 12:48

Manufacturer products View details

One Lambda Devyser Accept cfDNA

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

Manufacturer: Devyser AB
Manufacturer SRN: SE-MF-000001699
UDI-DI: 07350040631751
Basic UDI-DI: 7350040638R114RC
Reference: 8-R114-24
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 30.06.2026 12:48

Manufacturer products View details

One Lambda Devyser Accept cfDNA

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

Manufacturer: Devyser AB
Manufacturer SRN: SE-MF-000001699
UDI-DI: 07350040631744
Basic UDI-DI: 7350040638R114RC
Reference: 8-R114-8
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 30.06.2026 12:48

Manufacturer products View details

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

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

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

ß-THALASSAEMIA & HbA1c Reagent Kit (HPLC)

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06970341680459
Basic UDI-DI: 69703416803202027HS
Reference: 0320201205
EMDN: W0106010111
EMDN description: THALASSAEMIA
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 30.06.2026 01:53

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® IDH1/2 Detection & Differentiation Kit

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08908015304255
Basic UDI-DI: 89080153043B1338LE
Reference: 3B1337
EMDN: W0106010299
EMDN description: POLYGENETIC DISORDERS TESTS - OTHER
First on market country: -
Authorised representative: Wellkang Ltd
Last updated: 29.06.2026 11:20

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® BCR-ABL Kit – Quantitative Major (WHO IS) Minor & Micro

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08908015304446
Basic UDI-DI: 89080153043B1267LG
Reference: 3B1268
EMDN: W0106010299
EMDN description: POLYGENETIC DISORDERS TESTS - OTHER
First on market country: -
Authorised representative: Wellkang Ltd
Last updated: 29.06.2026 11:20

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® BCR-ABL Kit – Quantitative Major (WHO IS) Minor & Micro

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08908015304484
Basic UDI-DI: 89080153043B1267LG
Reference: 3B1267/C
EMDN: W0106010299
EMDN description: POLYGENETIC DISORDERS TESTS - OTHER
First on market country: -
Authorised representative: Wellkang Ltd
Last updated: 29.06.2026 11:20

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® BCR-ABL Kit - Minor Quantitative

IVD Class CIVDR 2017/746On the marketKitReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08908015304507
Basic UDI-DI: 89080153043B1291LD
Reference: 3B1292
EMDN: W0106010299
EMDN description: POLYGENETIC DISORDERS TESTS - OTHER
First on market country: -
Authorised representative: Wellkang Ltd
Last updated: 29.06.2026 11:20

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® MGMT Methylation Detection Kit

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08908015304705
Basic UDI-DI: 89080153043B1339LG
Reference: 3B1340
EMDN: W0106010299
EMDN description: POLYGENETIC DISORDERS TESTS - OTHER
First on market country: -
Authorised representative: Wellkang Ltd
Last updated: 29.06.2026 11:20

Manufacturer products Authorised representative products Authorised representative actors View details

ThromboGUARD FII FV

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: APPOLON BIOTECK
Manufacturer SRN: FR-MF-000022234
UDI-DI: 03760322820157
Basic UDI-DI: 376032282CGENF2F5FW
Reference: AB0040
EMDN: W0106010115
EMDN description: COMBINED FACTOR II / FACTOR V LEIDEN
First on market country: -
Authorised representative: -
Last updated: 29.06.2026 09:00

Manufacturer products View details

HLAB27GUARD

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: APPOLON BIOTECK
Manufacturer SRN: FR-MF-000022234
UDI-DI: 03760322820164
Basic UDI-DI: 376032282CGENHLAB27J6
Reference: AB0039
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: -
Authorised representative: -
Last updated: 29.06.2026 09:00

Manufacturer products View details

06955792731097

α-Thalassemia Gene Diagnostic Kit(gap-PCR)

IVD generalIVDDNo longer on the marketCompanion diagnosticsKitProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792731097
Basic UDI-DI: B-06955792731097
Reference: S3045E
EMDN: W0106010111
EMDN description: THALASSAEMIA
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

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: 06950996004541
Basic UDI-DI: B-06950996004541
Reference: N7001B
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

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

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