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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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Last updated

21.09.2026 21:15

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Device

3193421

Actor

47657

Certificate

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Active filter:EMDN:W01019001

517 device results listed.

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Oncotype® Sample Prep Kit

Oncotype Sample Prep Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent
Manufacturer
Genomic Health Inc.
Manufacturer SRN
US-MF-000018730
UDI-DI
00852867008053
Basic UDI-DI
0852867008100407DJ
Reference
100422
EMDN
W01019001
EMDN description
BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country
Germany
Authorised representative
QbD RepS BV
Last updated
16.07.2026 06:35
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Dimension Vista V-LYTE Dilution Check

IVDR_67_GLA_DUB-C_A_REAG_V-LYTE Dilution Check

IVD Class AIVDR 2017/746On the marketProfessional testingReagent
Manufacturer
Siemens Healthcare Diagnostics Inc.
Manufacturer SRN
US-MF-000016336
UDI-DI
00842768016257
Basic UDI-DI
0405686901045UY
Reference
10445203
EMDN
W01019001
EMDN description
BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country
Germany
Authorised representative
Siemens Healthcare Diagnostics Manufacturing Limited
Last updated
16.07.2026 00:29
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Dimension Vista V-LYTE Diluent

IVDR_67_GLA_DUB-C_A_REAG_V-LYTE Diluent

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use
Manufacturer
Siemens Healthcare Diagnostics Inc.
Manufacturer SRN
US-MF-000016336
UDI-DI
00842768016240
Basic UDI-DI
0405686901044UW
Reference
10445202
EMDN
W01019001
EMDN description
BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country
Germany
Authorised representative
Siemens Healthcare Diagnostics Manufacturing Limited
Last updated
16.07.2026 00:29
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Aptiva System Cleaning Solution Kit

Aptiva System Cleaning Solution Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use
Manufacturer
Inova Diagnostics. Inc.
Manufacturer SRN
US-MF-000017851
UDI-DI
00195126000871
Basic UDI-DI
0195126000871QG
Reference
AC1003
EMDN
W01019001
EMDN description
BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country
Italy
Authorised representative
Medical Technology Promedt Consulting GmbH
Last updated
15.07.2026 23:03
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
PGDx elio diversiPhi

A0840101

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent
Manufacturer
Personal Genome Diagnostics, Inc.
Manufacturer SRN
US-MF-000026862
UDI-DI
00192721001241
Basic UDI-DI
0192721U0200400P3
Reference
A0840101
EMDN
W01019001
EMDN description
BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country
Germany
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 23:03
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
ESR-Krebs HEPES Buffer VIT

ESR-Krebs HEPES Buffer VIT

IVD generalIVDDOn the marketReagentSingle use
Manufacturer
Noxygen Science Transfer & Diagnostics GmbH
Manufacturer SRN
DE-MF-000024761
UDI-DI
D-ESRKrebsHEPESPufferD5
Basic UDI-DI
B-ESRKrebsHEPESPufferD5
Reference
NOX-21.2-VIT
EMDN
W01019001
EMDN description
BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country
Germany
Authorised representative
-
Last updated
13.07.2026 21:02
Manufacturer productsView details
PVT5 (Precision and Accuracy Check)

PVT5 (Precision and Accuracy Check)

IVD generalIVDDOn the marketProfessional testingReagent
Manufacturer
Beckman Coulter Inc.
Manufacturer SRN
US-MF-000010288
UDI-DI
D-472055PX
Basic UDI-DI
B-472055PX
Reference
472055
EMDN
W01019001
EMDN description
BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country
Ireland
Authorised representative
Beckman Coulter Ireland Inc.
Last updated
11.07.2026 19:57
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
PVT2 (Buffer Blank And Cuvette Dryness Test)

PVT2 (Buffer Blank And Cuvette Dryness Test)

IVD generalIVDDOn the marketProfessional testingReagent
Manufacturer
Beckman Coulter Inc.
Manufacturer SRN
US-MF-000010288
UDI-DI
D-442831PQ
Basic UDI-DI
B-442831PQ
Reference
442831
EMDN
W01019001
EMDN description
BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country
Ireland
Authorised representative
Beckman Coulter Ireland Inc.
Last updated
11.07.2026 19:46
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
PVT3 (Combined Carryover Test)

PVT3 (Combined Carryover Test)

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent
Manufacturer
Beckman Coulter Inc.
Manufacturer SRN
US-MF-000010288
UDI-DI
D-442830PN
Basic UDI-DI
B-442830PN
Reference
442830
EMDN
W01019001
EMDN description
BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country
Ireland
Authorised representative
Beckman Coulter Ireland Inc.
Last updated
11.07.2026 19:46
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Z-Hb Confirm Reagent Kit (HPLC)

Z-Hb Confirm Reagent Kit (HPLC)

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
ZOVEC diagnostics GmbH
Manufacturer SRN
DE-MF-000035393
UDI-DI
42625753901396
Basic UDI-DI
B-42625753901396
Reference
Z-RHB
EMDN
W01019001
EMDN description
BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country
Germany
Authorised representative
-
Last updated
11.07.2026 19:42
Manufacturer productsView details
Daily Cleaners kit

Daily Cleaners kit

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
ZOVEC diagnostics GmbH
Manufacturer SRN
DE-MF-000035393
UDI-DI
42625753900238
Basic UDI-DI
B-42625753900238
Reference
ZA-EC1
EMDN
W01019001
EMDN description
BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country
Germany
Authorised representative
-
Last updated
11.07.2026 19:42
Manufacturer productsView details
CONTROL DILUTION SET 80

CONTROL DILUTION SET 80

IVD generalIVDDNo longer on the marketProfessional testingReagent
Manufacturer
ARKRAY Factory, Inc.
Manufacturer SRN
JP-MF-000003008
UDI-DI
D-42512G8
Basic UDI-DI
B-42512G8
Reference
42512
EMDN
W01019001
EMDN description
BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country
Italy
Authorised representative
ARKRAY Europe, B.V.
Last updated
11.07.2026 19:17
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
HEMOLYSIS WASHING SOLUTION 80H

HEMOLYSIS WASHING SOLUTION 80H

IVD generalIVDDOn the marketProfessional testingReagent
Manufacturer
ARKRAY Factory, Inc.
Manufacturer SRN
JP-MF-000003008
UDI-DI
D-42511G6
Basic UDI-DI
B-42511G6
Reference
42511
EMDN
W01019001
EMDN description
BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country
Italy
Authorised representative
ARKRAY Europe, B.V.
Last updated
11.07.2026 19:17
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details