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A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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680 device results listed.

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Oncomine™ Dx Target RNA Control Diluent

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IVD Class CIVDR 2017/746On the marketCompanion diagnosticsKitProfessional testingReagent

Manufacturer: Life Technologies Corporation
Manufacturer SRN: US-MF-000023929
UDI-DI: 10190302019651
Basic UDI-DI: 0190302A49756TV
Reference: A65537 (A65538)
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: -
Authorised representative: Life Technologies Europe B.V.
Last updated: 29.06.2026 10:50

Manufacturer products Authorised representative products Authorised representative actors View details

Ion Torrent™ Dx No Template Control Kit

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IVD Class CIVDR 2017/746On the marketCompanion diagnosticsKitProfessional testingReagent

Manufacturer: Life Technologies Corporation
Manufacturer SRN: US-MF-000023929
UDI-DI: 10190302019668
Basic UDI-DI: 0190302A49756TV
Reference: A65539 (A65538)
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: -
Authorised representative: Life Technologies Europe B.V.
Last updated: 29.06.2026 10:50

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® BCR-ABL Kit – Qualitative Major

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IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213930146
Basic UDI-DI: 89080153043B1201KJ
Reference: 3B1201/C
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: -
Authorised representative: Wellkang Ltd
Last updated: 27.06.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® BCR-ABL Kit – Qualitative Major

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IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213930139
Basic UDI-DI: 89080153043B1201KJ
Reference: 3B1202
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: -
Authorised representative: Wellkang Ltd
Last updated: 27.06.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® BCR-ABL Kit – Qualitative Major & Minor

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IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213930160
Basic UDI-DI: 89080153043B1203KN
Reference: 3B1203
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: -
Authorised representative: Wellkang Ltd
Last updated: 27.06.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® BCR-ABL Kit – Qualitative Major & Minor

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IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213930177
Basic UDI-DI: 89080153043B1203KN
Reference: 3B1204
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: -
Authorised representative: Wellkang Ltd
Last updated: 27.06.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® PML-RARA Kit - Qualitative

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IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213930214
Basic UDI-DI: 89080153043B1297LR
Reference: 3B1258
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: -
Authorised representative: Wellkang Ltd
Last updated: 27.06.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® PML-RARA Kit - Qualitative

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IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213930221
Basic UDI-DI: 89080153043B1297LR
Reference: 3B1255
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: -
Authorised representative: Wellkang Ltd
Last updated: 27.06.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® MYD88 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: 08906213930580
Basic UDI-DI: 89080153043B1427LE
Reference: 3B1427
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - 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® MYD88 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: 08906213930597
Basic UDI-DI: 89080153043B1427LE
Reference: 3B1428
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - 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® Leukemia Fusion Panel 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: 08906213930610
Basic UDI-DI: 89080153043B1404L2
Reference: 3B1410
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - 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® PIK3CA 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: 08906213930641
Basic UDI-DI: 89080153043B1345LB
Reference: 3B1346
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - 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® CXCR4 Mutations 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: 08906213930696
Basic UDI-DI: 89080153043B1425LA
Reference: 3B1425
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - 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® CXCR4 Mutations 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: 08906213930702
Basic UDI-DI: 89080153043B1425LA
Reference: 3B1426
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - 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® C-Kit 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: 08906213930733
Basic UDI-DI: 89080153043B1341L3
Reference: 3B1342
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - 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

ATM Deletion Probe

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IVD Class CNot specifiedOn the market

Manufacturer: Cytocell Limited
Manufacturer SRN: GB-MF-000016893
UDI-DI: 05055844906211
Basic UDI-DI: 50558449LPH011J4
Reference: CE-LPH 011-S
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
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

MLL (KMT2A) Breakapart Probe

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IVD Class CNot specifiedOn the market

Manufacturer: Cytocell Limited
Manufacturer SRN: GB-MF-000016893
UDI-DI: 05055844906259
Basic UDI-DI: 50558449LPH013J8
Reference: CE-LPH 013-S
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
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

Del(20q) Deletion Probe

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IVD Class CNot specifiedOn the market

Manufacturer: Cytocell Limited
Manufacturer SRN: GB-MF-000016893
UDI-DI: 05055844906334
Basic UDI-DI: 50558449LPH020J5
Reference: CE-LPH 020-S
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
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

Del(5q) Deletion Probe

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IVD Class CNot specifiedOn the market

Manufacturer: Cytocell Limited
Manufacturer SRN: GB-MF-000016893
UDI-DI: 05055844906372
Basic UDI-DI: 50558449LPH024JD
Reference: CE-LPH 024-S
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
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

Del(7q) Deletion Probe

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IVD Class CNot specifiedOn the market

Manufacturer: Cytocell Limited
Manufacturer SRN: GB-MF-000016893
UDI-DI: 05055844906396
Basic UDI-DI: 50558449LPH025JF
Reference: CE-LPH 025-S
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
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