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EUDAMED Device Search

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

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Active filter:EMDN:W010699

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T Cell Receptor Gamma Gene Rearrangement

T Cell Receptor Gamma Gene Rearrangement Assay 2.0 Megakit

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
Invivoscribe, Inc.
Manufacturer SRN
US-MF-000011736
UDI-DI
00850052003630
Basic UDI-DI
B-00850052003630
Reference
9-207-0111
EMDN
W010699
EMDN description
GENETIC TESTS - OTHER
First on market country
Austria
Authorised representative
IN VIVOSCRIBE TECHNOLOGIES
Last updated
05.07.2026 11:03
T Cell Receptor Gamma Gene Rearrangement

T Cell Receptor Gamma Gene Rearrangement Assay 2.0

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
Invivoscribe, Inc.
Manufacturer SRN
US-MF-000011736
UDI-DI
00850052003623
Basic UDI-DI
B-00850052003623
Reference
9-207-0101
EMDN
W010699
EMDN description
GENETIC TESTS - OTHER
First on market country
Austria
Authorised representative
IN VIVOSCRIBE TECHNOLOGIES
Last updated
05.07.2026 11:03
IGH Gene Clonality Assay

IGH Gene Clonality Assay MegaKit for ABI Fluorescence Detection

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
Invivoscribe, Inc.
Manufacturer SRN
US-MF-000011736
UDI-DI
00850052003159
Basic UDI-DI
B-00850052003159
Reference
9-101-0081
EMDN
W010699
EMDN description
GENETIC TESTS - OTHER
First on market country
Austria
Authorised representative
IN VIVOSCRIBE TECHNOLOGIES
Last updated
05.07.2026 11:03
IGH Gene Clonality Assay

IGH Gene Clonality Assay for ABI Fluorescence Detection

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
Invivoscribe, Inc.
Manufacturer SRN
US-MF-000011736
UDI-DI
00850052003142
Basic UDI-DI
B-00850052003142
Reference
9-101-0061
EMDN
W010699
EMDN description
GENETIC TESTS - OTHER
First on market country
Austria
Authorised representative
IN VIVOSCRIBE TECHNOLOGIES
Last updated
05.07.2026 11:03
00850024414044

Prosigna Breast Cancer Prognostic Gene Signature Assay

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Veracyte, Inc
Manufacturer SRN
US-MF-000048711
UDI-DI
00850024414044
Basic UDI-DI
B-00850024414044
Reference
PROSIGNA-002; PROSIGNA-003; PROSIGNA-004; PROSIGNA-010
EMDN
W010699
EMDN description
GENETIC TESTS - OTHER
First on market country
France
Authorised representative
Veracyte Global BV
Last updated
05.07.2026 11:00
Human BCR-ABL Fusion Gene Mutation Detection Kit (Fluorescence PCR)

Human BCR-ABL Fusion Gene Mutation Detection Kit (Fluorescence PCR)

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN
CN-MF-000012807
UDI-DI
D-0000128071500B3PT
Basic UDI-DI
B-0000128071500B3PT
Reference
HWTS-GE010
EMDN
W010699
EMDN description
GENETIC TESTS - OTHER
First on market country
Spain
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
04.07.2026 08:58
IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent
Manufacturer
CleanNA B.V.
Manufacturer SRN
NL-MF-000022870
UDI-DI
08720299808768
Basic UDI-DI
87202998087CBT7F
Reference
CBTDx-D0384
EMDN
W010699
EMDN description
GENETIC TESTS - OTHER
First on market country
Netherlands
Authorised representative
-
Last updated
03.07.2026 19:53
Laborant Total Nucleic Acid Extraction NS Kit (480)

Laborant Total Nucleic Acid Extraction NS Kit (480)

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use
Manufacturer
ANT MEDİKAL İTHALAT İHRACAT PAZARLAMA SANAYİ VE TİCARET LİMİTED ŞİRKETİ
Manufacturer SRN
TR-MF-000033765
UDI-DI
08683808252097
Basic UDI-DI
8683808252097CZ
Reference
LE-01-480
EMDN
W010699
EMDN description
GENETIC TESTS - OTHER
First on market country
Türkiye
Authorised representative
-
Last updated
03.07.2026 18:16
Laborant Total Nucleic Acid Extraction Kit (96)

Laborant Total Nucleic Acid Extraction Kit (96)

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use
Manufacturer
ANT MEDİKAL İTHALAT İHRACAT PAZARLAMA SANAYİ VE TİCARET LİMİTED ŞİRKETİ
Manufacturer SRN
TR-MF-000033765
UDI-DI
08683808252080
Basic UDI-DI
8683808252080CG
Reference
LE-01-96
EMDN
W010699
EMDN description
GENETIC TESTS - OTHER
First on market country
Türkiye
Authorised representative
-
Last updated
03.07.2026 18:16
Laborant Total Nucleic Acid Extraction Kit (48)

Laborant Total Nucleic Acid Extraction Kit (48)

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use
Manufacturer
ANT MEDİKAL İTHALAT İHRACAT PAZARLAMA SANAYİ VE TİCARET LİMİTED ŞİRKETİ
Manufacturer SRN
TR-MF-000033765
UDI-DI
08683808252073
Basic UDI-DI
8683808252073CK
Reference
LE-01-48
EMDN
W010699
EMDN description
GENETIC TESTS - OTHER
First on market country
Türkiye
Authorised representative
-
Last updated
03.07.2026 18:16
MULTIGEN

FAST-GBA NGS SEQUENCING KIT / Yeni Nesil Dizi Analizi ile GBA Mutasyonlarını Saptama Kiti

IVD Class CIVDR 2017/746On the marketDirect markingKitMicrobial substancesReagentSingle use
Manufacturer
MULTİGEN SAĞLIK HİZ. TİC. LTD. ŞTİ.
Manufacturer SRN
TR-MF-000050129
UDI-DI
8681957090409ED
Basic UDI-DI
8681957090409ED
Reference
M-GBA-01
EMDN
W010699
EMDN description
GENETIC TESTS - OTHER
First on market country
Türkiye
Authorised representative
-
Last updated
03.07.2026 17:40
MULTIGEN

FAST-EXT1/EXT2 NGS SEQUENCING KIT / Yeni Nesil Dizi Analizi ile EXT1 ve EXT2 Mutasyonlarını Saptama Kiti

IVD Class CIVDR 2017/746On the marketDirect markingKitMicrobial substancesReagentSingle use
Manufacturer
MULTİGEN SAĞLIK HİZ. TİC. LTD. ŞTİ.
Manufacturer SRN
TR-MF-000050129
UDI-DI
8681957090393EP
Basic UDI-DI
8681957090393EP
Reference
M-EXT-01
EMDN
W010699
EMDN description
GENETIC TESTS - OTHER
First on market country
Türkiye
Authorised representative
-
Last updated
03.07.2026 17:40
MULTIGEN

FAST-HFE NGS SEQUENCING KIT / Yeni Nesil Dizi Analizi ile HFE Mutasyonlarını Saptama Kiti

IVD Class CIVDR 2017/746On the marketDirect markingKitMicrobial substancesReagentSingle use
Manufacturer
MULTİGEN SAĞLIK HİZ. TİC. LTD. ŞTİ.
Manufacturer SRN
TR-MF-000050129
UDI-DI
8681957090386ES
Basic UDI-DI
8681957090386ES
Reference
M-HFE-01
EMDN
W010699
EMDN description
GENETIC TESTS - OTHER
First on market country
Türkiye
Authorised representative
-
Last updated
03.07.2026 17:40
MULTIGEN

FAST-F7 NGS SEQUENCING KIT / Yeni Nesil Dizi Analizi ile F7 Mutasyonlarını Saptama Kiti

IVD Class CIVDR 2017/746On the marketDirect markingKitMicrobial substancesReagentSingle use
Manufacturer
MULTİGEN SAĞLIK HİZ. TİC. LTD. ŞTİ.
Manufacturer SRN
TR-MF-000050129
UDI-DI
8681957090379EV
Basic UDI-DI
8681957090379EV
Reference
M-F7-01
EMDN
W010699
EMDN description
GENETIC TESTS - OTHER
First on market country
Türkiye
Authorised representative
-
Last updated
03.07.2026 17:40
MULTIGEN

FAST-GAA NGS SEQUENCING KIT / Yeni Nesil Dizi Analizi ile GAA Mutasyonlarını Saptama Kiti

IVD Class CIVDR 2017/746On the marketDirect markingKitMicrobial substancesReagentSingle use
Manufacturer
MULTİGEN SAĞLIK HİZ. TİC. LTD. ŞTİ.
Manufacturer SRN
TR-MF-000050129
UDI-DI
8681957090362EC
Basic UDI-DI
8681957090362EC
Reference
M-GAA-01
EMDN
W010699
EMDN description
GENETIC TESTS - OTHER
First on market country
Türkiye
Authorised representative
-
Last updated
03.07.2026 17:40
MULTIGEN

FAST-VWF Yeni Nesil Dizi Analizi ile VWF Mutasyonlarını Saptama Kiti

IVD Class CIVDR 2017/746On the marketDirect markingKitMicrobial substancesReagentSingle use
Manufacturer
MULTİGEN SAĞLIK HİZ. TİC. LTD. ŞTİ.
Manufacturer SRN
TR-MF-000050129
UDI-DI
8681957090355EF
Basic UDI-DI
8681957090355EF
Reference
M-VWF-01
EMDN
W010699
EMDN description
GENETIC TESTS - OTHER
First on market country
Türkiye
Authorised representative
-
Last updated
03.07.2026 17:40