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

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92 device results listed.

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HLA B5701 Strip

3.155.XXX.YY.ZZZ

IVD Class CIVDR 2017/746On the marketAnimal tissuesCompanion diagnosticsKitProfessional testingReagent

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577002903
Basic UDI-DI: 84295773155WV
Reference: 3.155.016.53.000
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Spain
Safety summary (SSCP/SSP): DO-040131 HLA B5701 Strip · Rev. 02
Authorised representative: -
Last updated: 07.08.2026 13:40

Manufacturer products Open in EUDAMED View details

HLA B5701 Strip

IVD Class CIVDR 2017/746On the marketAnimal tissuesCompanion diagnosticsKitProfessional testingReagent

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577002910
Basic UDI-DI: 84295773155WV
Reference: 3.155.048.53.000
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: -
Safety summary (SSCP/SSP): DO-040131 HLA B5701 Strip · Rev. 02
Authorised representative: -
Last updated: 07.08.2026 13:37

Manufacturer products Open in EUDAMED View details

Simple Rotavirus / Stick Rotavirus

9.333.XXX.YY.ZZZ

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: D-84295779333Y7HJ
Basic UDI-DI: B-84295779333Y7HJ
Reference: 9.333.XXX.YY.ZZZ
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:09

Manufacturer products View details

Simple Ag SARS-CoV-2 / Flu A+B

9.242.XXX.YY.ZZZ

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: D-84295779242Y3GZ
Basic UDI-DI: B-84295779242Y3GZ
Reference: 9.242.XXX.YY.ZZZ
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:09

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Simple/Stick Campylobacter

9.230.XXX.YY.ZZZ

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: D-84295779230XUJF
Basic UDI-DI: B-84295779230XUJF
Reference: 9.230.XXX.YY.ZZZ
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:09

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CONTROL POSITIVO EN SECO CAMPYLOBACTER / CAMPYLOBACTER DRY POSITIVE CONTROL

9.230.XXX.12.ZZZ

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: D-8429577923012CR23
Basic UDI-DI: B-8429577923012CR23
Reference: 9.230.XXX.12.ZZZ
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:09

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SIMPLE ENTAMOEBA / STICK ENTAMOEBA

9.143.XXX.YY.ZZZ

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: D-84295779143XYK2
Basic UDI-DI: B-84295779143XYK2
Reference: 9.143.XXX.YY.ZZZ
EMDN: W0105090499
EMDN description: PARASITES - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:09

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SIMPLE Strep pneumo-Legio / STICK Strep pneumo-Legio

9.108.XXX.YY.ZZZ

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: D-84295779108XWJT
Basic UDI-DI: B-84295779108XWJT
Reference: 9.108.XXX.YY.ZZZ
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:09

Manufacturer products View details

CONTROL POSITIVO STREP PNEUMO-LEGIO / STREP PNEUMO-LEGIO POSITIVE CONTROL

9.108.XXX.37.ZZZ

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: D-8429577910837DH3R
Basic UDI-DI: B-8429577910837DH3R
Reference: 9.108.XXX.37.ZZZ
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:09

Manufacturer products View details

SIMPLE Strep pneumo / STICK Strep pneumo

9.107.XXX.YY.ZZZ

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: D-84295779107XUJJ
Basic UDI-DI: B-84295779107XUJJ
Reference: 9.107.XXX.YY.ZZZ
EMDN: W0105090109
EMDN description: STREP. PNEUMONIAE - RT & POC
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:09

Manufacturer products View details

SIMPLE Legio pneumo / STICK Legio pneumo

9.106.XXX.YY.ZZZ

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: D-84295779106XSJ9
Basic UDI-DI: B-84295779106XSJ9
Reference: 9.106.XXX.YY.ZZZ
EMDN: W0105090108
EMDN description: LEGIONELLA - RT & POC
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:09

Manufacturer products View details

Simple H.pyl / Stick H.pyl

9.076.XXX.YY.ZZZ

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: D-84295779076YAJE
Basic UDI-DI: B-84295779076YAJE
Reference: 9.076.XXX.YY.ZZZ
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:09

Manufacturer products View details

Simple Calprotectina

9.049.XXX.YY.ZZZ

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: D-84295779049Y7HN
Basic UDI-DI: B-84295779049Y7HN
Reference: 9.049.XXX.YY.ZZZ
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:09

Manufacturer products View details

CONTROL POSITIVO EN SECO CALPROTECTINA || DRY CALPROTECTIN POSITIVE CONTROL

9.049.XXX.12.ZZZ

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: D-8429577904912DP4G
Basic UDI-DI: B-8429577904912DP4G
Reference: 9.049.XXX.12.ZZZ
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:09

Manufacturer products View details

SIMPLE 2A-Bdiff / STICK 2A-Bdiff

9.038.XXX.YY.ZZZ

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: D-84295779038Y2GY
Basic UDI-DI: B-84295779038Y2GY
Reference: 9.038.XXX.YY.ZZZ
EMDN: W0105090106
EMDN description: CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:08

Manufacturer products View details

SIMPLE CD1WB

9.028.XXX.YY.ZZZ

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: D-84295779028XXJY
Basic UDI-DI: B-84295779028XXJY
Reference: 9.028.XXX.YY.ZZZ
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:08

Manufacturer products View details

Simple Norovirus / Stick Norovirus

9.041.XXX.YY.ZZZ

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: D-84295779041XPHT
Basic UDI-DI: B-84295779041XPHT
Reference: 9.041.XXX.YY.ZZZ
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:08

Manufacturer products View details

SIMPLE CD2WB

9.029.XXX.YY.ZZZ

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: D-84295779029XZK9
Basic UDI-DI: B-84295779029XZK9
Reference: 9.029.XXX.YY.ZZZ
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:08

Manufacturer products View details

SIMPLE CRYPTO-GIARDIA / STICK CRYPTO-GIARDIA

9.023.XXX.YY.ZZZ

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: D-84295779023XMHH
Basic UDI-DI: B-84295779023XMHH
Reference: 9.023.XXX.YY.ZZZ
EMDN: W0105090499
EMDN description: PARASITES - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:08

Manufacturer products View details

SIMPLE CRYPTO / STICK CRYPTO

9.022.XXX.YY.ZZZ

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: D-84295779022XKH8
Basic UDI-DI: B-84295779022XKH8
Reference: 9.022.XXX.YY.ZZZ
EMDN: W0105090499
EMDN description: PARASITES - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:08

Manufacturer products View details