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01.08.2026 01:12

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137 device results listed.

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ToRCH IgG Positive Control

105-024832-00、105-024833-00、105-024834-00、105-024835-00

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053021012
Basic UDI-DI: 69449040AB74000165K
Reference: 105-024834-00
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:47

Manufacturer products Authorised representative products Authorised representative actors View details

ToRCH IgM Positive Control

105-024840-00、105-024841-00、105-024842-00、105-024843-00

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053020947
Basic UDI-DI: 69449040AB74000175M
Reference: 105-024843-00
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:47

Manufacturer products Authorised representative products Authorised representative actors View details

ToRCH IgG/IgM Negative Control

105-024824-00、105-024825-00、105-024826-00、105-024827-00

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053020886
Basic UDI-DI: 69449040AB74000185P
Reference: 105-024824-00
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:47

Manufacturer products Authorised representative products Authorised representative actors View details

SEROLOGY NEGATIVE CONTROL (SEROLOGY CONTROL NEGATIVE)

SEROLOGY CONTROL

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273216493
Basic UDI-DI: 50552732BSECONT122LA
Reference: SR10351
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:12

Manufacturer products View details

SEROLOGY ToRCH NEGATIVE CONTROL (ToRCH CONTROL -)

SEROLOGY ToRCH CONTROL

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273216400
Basic UDI-DI: 50552732BSETECO123LF
Reference: SR10347
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:12

Manufacturer products View details

SEROLOGY LYME DISEASE NEGATIVE CONTROL (LYME CONTROL -)

SEROLOGY LYME DISEASE CONTROL

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273216387
Basic UDI-DI: 50552732BSELYDC124N4
Reference: SR10345
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:12

Manufacturer products View details

Optitrol HEPR-1

SR12047

IVD Class BIVDR 2017/746On the marketKitProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850075956975
Basic UDI-DI: 0816784020129Y6
Reference: SR12045
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 24.07.2026 06:50

Manufacturer products Authorised representative products Authorised representative actors View details

Optitrol Paediatric M Neg

SR15003

IVD Class BIVDR 2017/746On the marketKitProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850075956425
Basic UDI-DI: 0816784020127Y2
Reference: SR15005
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 24.07.2026 06:50

Manufacturer products Authorised representative products Authorised representative actors View details

Optitrol Paediatric G Pos

SR15015

IVD Class BIVDR 2017/746On the marketKitProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850075956364
Basic UDI-DI: 0816784020131XR
Reference: SR15017
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 24.07.2026 06:50

Manufacturer products Authorised representative products Authorised representative actors View details

Optitrol HEPR-1

IVD Class BIVDR 2017/746On the marketKitProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850075956982
Basic UDI-DI: 0816784020129Y6
Reference: SR12047
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: -
Authorised representative: MediMark Europe Sarl.
Last updated: 24.07.2026 06:46

Manufacturer products Authorised representative products Authorised representative actors View details

Optitrol Paediatric G Pos

IVD Class BIVDR 2017/746On the marketKitProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850075956371
Basic UDI-DI: 0816784020131XR
Reference: SR15015
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: -
Authorised representative: MediMark Europe Sarl.
Last updated: 24.07.2026 06:46

Manufacturer products Authorised representative products Authorised representative actors View details

Optitrol Paediatric M Neg

IVD Class BIVDR 2017/746On the marketKitProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850075956432
Basic UDI-DI: 0816784020127Y2
Reference: SR15003
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: -
Authorised representative: MediMark Europe Sarl.
Last updated: 24.07.2026 06:46

Manufacturer products Authorised representative products Authorised representative actors View details

70845357043749

8250

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

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 70845357043749
Basic UDI-DI: 084535708250B5
Reference: [8250] QC Sets and Panels: Helix Elite™ Candida vaginitis/Trichomonas vaginalis (CV/TV) Control Panel
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

70845357043732

8249

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

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 70845357043732
Basic UDI-DI: 084535708249BL
Reference: [8249] QC Sets and Panels: Helix Elite™ Bacterial Vaginosis (BV) Control Panel
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

70845357043619

8247

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

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 70845357043619
Basic UDI-DI: 084535708247BG
Reference: [8247] QC Sets and Panels: Helix Elite™ Respiratory Control Panel (22 Targets)
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

70845357043060

8236

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

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 70845357043060
Basic UDI-DI: 084535708236BB
Reference: [8236] QC Sets and Panels: Helix Elite™ Gastrointestinal (22 Targets) Control Panel (Inactivated Pellet)
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

70845357042681

8228

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

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 70845357042681
Basic UDI-DI: 084535708228BC
Reference: [8228] QC Sets and Panels: Helix Elite™ CT/GC/TV Control Panel (Inactivated Pellet)
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

70845357041448

8184

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

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 70845357041448
Basic UDI-DI: 084535708184BH
Reference: [8184] QC Sets and Panels: Helix Elite™ Enteric Pathogens Control Panel (Inactivated Pellet)
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

70845357041325

8209

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

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 70845357041325
Basic UDI-DI: 084535708209B8
Reference: [8209] QC Sets and Panels: Helix Elite™ Vaginal Control Panel
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:55

Manufacturer products Authorised representative products Authorised representative actors View details

70845357041318

8208

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

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 70845357041318
Basic UDI-DI: 084535708208B6
Reference: [8208] QC Sets and Panels: Helix Elite™ Vaginal Verification Panel
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:55

Manufacturer products Authorised representative products Authorised representative actors View details