Public EUDAMED Search

EUDAMED Device Search

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

Last updated

01.08.2026 18:27

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Active filter:EMDN:W0102

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IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
Diagnostics Biochem Canada Inc.
Manufacturer SRN
CA-MF-000032449
UDI-DI
++B261CANCRP4360XQ
Basic UDI-DI
B-++B261CANCRP4360XQ
Reference
CAN-CRP-4360
EMDN
W01021308
EMDN description
HIGH-SENSITIVITY C-.REACTIVE PROTEIN
First on market country
Netherlands
Authorised representative
MedEnvoy Global BV
Last updated
01.08.2026 01:39
IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
Diagnostics Biochem Canada Inc.
Manufacturer SRN
CA-MF-000032449
UDI-DI
++B261CANATP4160X6
Basic UDI-DI
B-++B261CANATP4160X6
Reference
CAN-ATP-4160
EMDN
W0102100301
EMDN description
THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country
Netherlands
Authorised representative
MedEnvoy Global BV
Last updated
01.08.2026 01:39
IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
Diagnostics Biochem Canada Inc.
Manufacturer SRN
CA-MF-000032449
UDI-DI
++B261CANAPN5000UC
Basic UDI-DI
B-++B261CANAPN5000UC
Reference
CAN-APN-5000
EMDN
W0102069099
EMDN description
INDIVIDUAL AND SPECIFIC HORMONES - OTHER
First on market country
Netherlands
Authorised representative
MedEnvoy Global BV
Last updated
01.08.2026 01:39
xPOC Cartridge

xPOC Cartridge

IVD Class AIVDR 2017/746On the marketNear-patient testingProfessional testingReagent
Manufacturer
GENSPEED Biotech
Manufacturer SRN
AT-MF-000013008
UDI-DI
09120131770038
Basic UDI-DI
912013177xPOCCartS4
Reference
GSPC2
EMDN
W01021699
EMDN description
RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country
Austria
Authorised representative
-
Last updated
01.08.2026 00:42
Vitamin D xPOC

Vitamin D xPOC

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use
Manufacturer
GENSPEED Biotech
Manufacturer SRN
AT-MF-000013008
UDI-DI
09120131770021
Basic UDI-DI
912013177VitaminD3CJ
Reference
IATK215
EMDN
W01021699
EMDN description
RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country
Austria
Authorised representative
-
Last updated
01.08.2026 00:42
09120122925072

Stop Solution

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent
Manufacturer
MacroArray Diagnostics
Manufacturer SRN
AT-MF-000030541
UDI-DI
09120122925072
Basic UDI-DI
9120122925076R
Reference
00-5007-01
EMDN
W01029003
EMDN description
BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country
Austria
Authorised representative
-
Last updated
01.08.2026 00:41
09120122925034

Washing Solution 4x conc.

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent
Manufacturer
MacroArray Diagnostics
Manufacturer SRN
AT-MF-000030541
UDI-DI
09120122925034
Basic UDI-DI
9120122925036H
Reference
00-5003-01
EMDN
W01029003
EMDN description
BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country
Austria
Authorised representative
-
Last updated
01.08.2026 00:41
09120122923009

ConfigXplorer

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testing
Manufacturer
MacroArray Diagnostics
Manufacturer SRN
AT-MF-000030541
UDI-DI
09120122923009
Basic UDI-DI
91201229230JV
Reference
30-0100-01
EMDN
W0102152299
EMDN description
STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country
Austria
Authorised representative
-
Last updated
01.08.2026 00:41
IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagent
Manufacturer
MacroArray Diagnostics
Manufacturer SRN
AT-MF-000030541
UDI-DI
09120122920756
Basic UDI-DI
91201229207K2
Reference
07-5001-01
EMDN
W01020205
EMDN description
IMMUNOGLOBULIN E - SCREEN
First on market country
Austria
Authorised representative
-
Last updated
01.08.2026 00:41
IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagent
Manufacturer
MacroArray Diagnostics
Manufacturer SRN
AT-MF-000030541
UDI-DI
09120122920657
Basic UDI-DI
91201229206JY
Reference
06-5001-01
EMDN
W01020205
EMDN description
IMMUNOGLOBULIN E - SCREEN
First on market country
Austria
Authorised representative
-
Last updated
01.08.2026 00:41
09120122920329

ALEX³ Allergy Xplorer

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagent
Manufacturer
MacroArray Diagnostics
Manufacturer SRN
AT-MF-000030541
UDI-DI
09120122920329
Basic UDI-DI
91201229203JS
Reference
03-2001-01
EMDN
W01020205
EMDN description
IMMUNOGLOBULIN E - SCREEN
First on market country
Austria
Authorised representative
-
Last updated
01.08.2026 00:41
09120122920220

ALEX² Allergy Xplorer

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagent
Manufacturer
MacroArray Diagnostics
Manufacturer SRN
AT-MF-000030541
UDI-DI
09120122920220
Basic UDI-DI
91201229202JQ
Reference
02-2001-01
EMDN
W01020205
EMDN description
IMMUNOGLOBULIN E - SCREEN
First on market country
Austria
Safety summary (SSCP/SSP)
TD-9_ALEX² - Summary of Safety and Performance (SSP)_v1.0 · Rev. v1.0
Authorised representative
-
Last updated
01.08.2026 00:41