Veriler yükleniyor…

Public EUDAMED Search

EUDAMED Device Search

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

Last updated

18.09.2026 16:00

Sync status

Successful

Device

3108040

Actor

47631

Certificate

3283

Filters

Show filters

Active filter:EMDN:W0105080899

79 device results listed.

Page 1 / 4

Optitrol Red

IVD Annex II List AIVDDOn the marketKitProfessional testingReagent

Manufacturer: DiaMex GmbH
Manufacturer SRN: DE-MF-000037219
UDI-DI: 04260465670309
Basic UDI-DI: B-04260465670309
Reference: SR11059
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 12:10

Manufacturer products View details

Optitrol Red

IVD Annex II List AIVDDOn the marketKitProfessional testingReagent

Manufacturer: DiaMex GmbH
Manufacturer SRN: DE-MF-000037219
UDI-DI: 04260465670293
Basic UDI-DI: B-04260465670293
Reference: SR11053
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 12:10

Manufacturer products View details

Optitrol Red

IVD Annex II List AIVDDOn the marketKitProfessional testingReagent

Manufacturer: DiaMex GmbH
Manufacturer SRN: DE-MF-000037219
UDI-DI: 04260465670286
Basic UDI-DI: B-04260465670286
Reference: SR11051
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 12:10

Manufacturer products View details

Optitrol Green

IVD Annex II List AIVDDOn the marketKitProfessional testingReagent

Manufacturer: DiaMex GmbH
Manufacturer SRN: DE-MF-000037219
UDI-DI: 04260465670279
Basic UDI-DI: B-04260465670279
Reference: SR11049
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 12:10

Manufacturer products View details

Optitrol Green

IVD Annex II List AIVDDOn the marketKitProfessional testingReagent

Manufacturer: DiaMex GmbH
Manufacturer SRN: DE-MF-000037219
UDI-DI: 04260465670262
Basic UDI-DI: B-04260465670262
Reference: SR11041
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 12:10

Manufacturer products View details

Optitrol Green

IVD Annex II List AIVDDOn the marketKitProfessional testingReagent

Manufacturer: DiaMex GmbH
Manufacturer SRN: DE-MF-000037219
UDI-DI: 04260465670255
Basic UDI-DI: B-04260465670255
Reference: SR11041
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 12:10

Manufacturer products View details

Optitrol Yellow

Optitrol Yellow

IVD Annex II List AIVDDOn the marketKitProfessional testingReagent

Manufacturer: DiaMex GmbH
Manufacturer SRN: DE-MF-000037219
UDI-DI: 04260465670217
Basic UDI-DI: B-04260465670217
Reference: SR11029
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 12:10

Manufacturer products View details

Optitrol Yellow

Optitrol Yellow

IVD Annex II List AIVDDOn the marketKitProfessional testingReagent

Manufacturer: DiaMex GmbH
Manufacturer SRN: DE-MF-000037219
UDI-DI: 04260465670200
Basic UDI-DI: B-04260465670200
Reference: SR11023
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 12:10

Manufacturer products View details

Optitrol Yellow

Optitrol Yellow

IVD Annex II List AIVDDOn the marketKitProfessional testingReagent

Manufacturer: DiaMex GmbH
Manufacturer SRN: DE-MF-000037219
UDI-DI: 04260465670194
Basic UDI-DI: B-04260465670194
Reference: SR11021
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 12:10

Manufacturer products View details

Optitrol Blue

IVD Annex II List AIVDDOn the marketKitProfessional testingReagent

Manufacturer: DiaMex GmbH
Manufacturer SRN: DE-MF-000037219
UDI-DI: 04260465670187
Basic UDI-DI: B-04260465670187
Reference: SR11019
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 12:10

Manufacturer products View details

Optitrol Blue

IVD Annex II List AIVDDOn the marketKitProfessional testingReagent

Manufacturer: DiaMex GmbH
Manufacturer SRN: DE-MF-000037219
UDI-DI: 04260465670170
Basic UDI-DI: B-04260465670170
Reference: SR11013
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 12:10

Manufacturer products View details

Optitrol Blue

IVD Annex II List AIVDDOn the marketKitProfessional testingReagent

Manufacturer: DiaMex GmbH
Manufacturer SRN: DE-MF-000037219
UDI-DI: 04260465670163
Basic UDI-DI: B-04260465670163
Reference: SR11011
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 12:10

Manufacturer products View details

SEROLOGY HBeAg POSITIVE CONTROL (HBeAg CONTROL +)

SEROLOGY HBeAg POSITIVE CONTROL

IVD Class BIVDR 2017/746On the marketNo EU repHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273217933
Basic UDI-DI: 50552732BHBPOCT140DS
Reference: SR10459
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:13

Manufacturer products View details

SEROLOGY HIV-1 P24Ag POSITIVE CONTROL (HIV-1 P24Ag CONTROL +)

SEROLOGY HIV-1 P24Ag POSITIVE CONTROL

IVD Class BIVDR 2017/746On the marketNo EU repHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273217100
Basic UDI-DI: 50552732BAGPOCO125AR
Reference: SR10458
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:12

Manufacturer products View details

Standard Gas

IVD Class BIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Otsuka Electronics Co., Ltd.
Manufacturer SRN: JP-MF-000001943
UDI-DI: 04987035485513
Basic UDI-DI: 498703502SG460644FU
Reference: UB-SP-012
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Spain
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 07:31

Manufacturer products Authorised representative products Authorised representative actors View details

Optitrol ToRCH G Neg

SR13019

IVD Class BIVDR 2017/746On the marketKitProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850075956593
Basic UDI-DI: 0816784020128Y4
Reference: SR13049
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 23.07.2026 22:43

Manufacturer products Authorised representative products Authorised representative actors View details

Optitrol ToRCH G Pos

-

IVD Class BIVDR 2017/746On the marketKitProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850075956623
Basic UDI-DI: 0816784020128Y4
Reference: SR13019
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: -
Authorised representative: MediMark Europe Sarl.
Last updated: 23.07.2026 22:36

Manufacturer products Authorised representative products Authorised representative actors View details

Optitrol ToRCH G Pos

-

IVD Class BIVDR 2017/746On the marketKitProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850075956609
Basic UDI-DI: 0816784020128Y4
Reference: SR13017
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: -
Authorised representative: MediMark Europe Sarl.
Last updated: 23.07.2026 22:36

Manufacturer products Authorised representative products Authorised representative actors View details

Optitrol ToRCH G Neg

-

IVD Class BIVDR 2017/746On the marketKitProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850075956616
Basic UDI-DI: 0816784020128Y4
Reference: SR13047
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: -
Authorised representative: MediMark Europe Sarl.
Last updated: 23.07.2026 22:36

Manufacturer products Authorised representative products Authorised representative actors View details

HE0067NS

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357043594
Basic UDI-DI: 08453570HE0067NS37
Reference: [HE0067NS] Helix Elite™ Molecular Standards Negative Cellularity Control (Inactivated Swab)
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:53

Manufacturer products Authorised representative products Authorised representative actors View details