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EUDAMED Device Search

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TREN

Last updated

01.08.2026 13:11

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Device

2989378

Actor

47520

Certificate

3174

Active filter:EMDN:W0105080807

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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsView 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 productsView 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 productsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView details