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EUDAMED Device Search

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TREN

Last updated

22.09.2026 01:15

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Device

3400347

Actor

47670

Certificate

3311

Active filter:EMDN:W01050502

308 device results listed.

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06955792735347

Cryptosporidium Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Sansure Biotech Inc.
Manufacturer SRN
CN-MF-000011392
UDI-DI
06955792735347
Basic UDI-DI
B-06955792735347
Reference
S3219E-48
EMDN
W0105050207
EMDN description
CRYPTOSPORIDIUM
First on market country
France
Authorised representative
Obelis s.a.
Last updated
03.08.2026 22:09
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06955792735330

Cryptosporidium Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Sansure Biotech Inc.
Manufacturer SRN
CN-MF-000011392
UDI-DI
06955792735330
Basic UDI-DI
B-06955792735330
Reference
S3219E-24
EMDN
W0105050207
EMDN description
CRYPTOSPORIDIUM
First on market country
France
Authorised representative
Obelis s.a.
Last updated
03.08.2026 22:08
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06955792734418

Giardia Lamblia Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Sansure Biotech Inc.
Manufacturer SRN
CN-MF-000011392
UDI-DI
06955792734418
Basic UDI-DI
B-06955792734418
Reference
S3233E-48
EMDN
W0105050208
EMDN description
GIARDIA LAMBLIA
First on market country
France
Authorised representative
Obelis s.a.
Last updated
03.08.2026 22:05
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06955792734401

Giardia Lamblia Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Sansure Biotech Inc.
Manufacturer SRN
CN-MF-000011392
UDI-DI
06955792734401
Basic UDI-DI
B-06955792734401
Reference
This product is manufactured by Sansure Biotech Inc..
EMDN
W0105050208
EMDN description
GIARDIA LAMBLIA
First on market country
France
Authorised representative
Obelis s.a.
Last updated
03.08.2026 22:05
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06955792734395

Entamoeba Histolytica Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Sansure Biotech Inc.
Manufacturer SRN
CN-MF-000011392
UDI-DI
06955792734395
Basic UDI-DI
B-06955792734395
Reference
S3230E-48
EMDN
W0105050201
EMDN description
ENTAMOEBA HISTOLYTICA
First on market country
France
Authorised representative
Obelis s.a.
Last updated
03.08.2026 22:05
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06955792734388

Entamoeba Histolytica Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Sansure Biotech Inc.
Manufacturer SRN
CN-MF-000011392
UDI-DI
06955792734388
Basic UDI-DI
B-06955792734388
Reference
S3230E-24
EMDN
W0105050201
EMDN description
ENTAMOEBA HISTOLYTICA
First on market country
France
Authorised representative
Obelis s.a.
Last updated
03.08.2026 22:05
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Plasmodium Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

Plasmodium Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDNo longer on the marketKitMicrobial substancesProfessional testingReagent
Manufacturer
Sansure Biotech Inc.
Manufacturer SRN
CN-MF-000011392
UDI-DI
06955792734234
Basic UDI-DI
B-06955792734234
Reference
S3187E-24
EMDN
W0105050209
EMDN description
PLASMODIUM (MALARIA)
First on market country
-
Authorised representative
Obelis s.a.
Last updated
03.08.2026 22:04
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Plasmodium DNA Diagnostic Kit (PCR-Fluorescence Probing)

Plasmodium DNA Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent
Manufacturer
Sansure Biotech Inc.
Manufacturer SRN
CN-MF-000011392
UDI-DI
06955792733336
Basic UDI-DI
B-06955792733336
Reference
S3093E
EMDN
W0105050209
EMDN description
PLASMODIUM (MALARIA)
First on market country
France
Authorised representative
Obelis s.a.
Last updated
03.08.2026 21:59
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06955792732636

Cryptosporidium/Entamoeba histolytica/Giardia lamblia Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Sansure Biotech Inc.
Manufacturer SRN
CN-MF-000011392
UDI-DI
06955792732636
Basic UDI-DI
B-06955792732636
Reference
S3227E-48
EMDN
W0105050299
EMDN description
PARASITOLOGY - OTHER
First on market country
France
Authorised representative
Obelis s.a.
Last updated
03.08.2026 21:58
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06955792732629

Cryptosporidium/Entamoeba histolytica/Giardia lamblia Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Sansure Biotech Inc.
Manufacturer SRN
CN-MF-000011392
UDI-DI
06955792732629
Basic UDI-DI
B-06955792732629
Reference
S3227E-24
EMDN
W0105050299
EMDN description
PARASITOLOGY - OTHER
First on market country
France
Authorised representative
Obelis s.a.
Last updated
03.08.2026 21:58
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Toxocara canis IgG ELISA

Toxocara canis IgG ELISA

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent
Manufacturer
Bordier Affinity Products SA
Manufacturer SRN
CH-MF-000025247
UDI-DI
07640158219201
Basic UDI-DI
764015821920029
Reference
9200
EMDN
W0105050299
EMDN description
PARASITOLOGY - OTHER
First on market country
France
Authorised representative
Leman Diagnostics SARL
Last updated
01.08.2026 10:28
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Ascaris IgG ELISA

Ascaris IgG ELISA

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent
Manufacturer
Bordier Affinity Products SA
Manufacturer SRN
CH-MF-000025247
UDI-DI
07640158219256
Basic UDI-DI
76401582192502Q
Reference
9250
EMDN
W0105050299
EMDN description
PARASITOLOGY - OTHER
First on market country
France
Authorised representative
Leman Diagnostics SARL
Last updated
01.08.2026 10:28
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Echinococcus multilocularis (Em2- Em18) IgG ELISA

Echinococcus multilocularis (Em2- Em18) IgG ELISA

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent
Manufacturer
Bordier Affinity Products SA
Manufacturer SRN
CH-MF-000025247
UDI-DI
07640158219300
Basic UDI-DI
76401582193002E
Reference
9300
EMDN
W0105050204
EMDN description
ECHINOCOCCUS
First on market country
France
Authorised representative
Leman Diagnostics SARL
Last updated
01.08.2026 10:28
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Echinococcus multilocularis (Em18) IgG ELISA

Echinococcus multilocularis (Em18) IgG ELISA

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent
Manufacturer
Bordier Affinity Products SA
Manufacturer SRN
CH-MF-000025247
UDI-DI
07640158219317
Basic UDI-DI
76401582193102H
Reference
9310
EMDN
W0105050204
EMDN description
ECHINOCOCCUS
First on market country
France
Authorised representative
Leman Diagnostics SARL
Last updated
01.08.2026 10:28
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Echinococcus granulosus IgG ELISA

Echinococcus granulosus IgG ELISA

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent
Manufacturer
Bordier Affinity Products SA
Manufacturer SRN
CH-MF-000025247
UDI-DI
07640158219355
Basic UDI-DI
76401582193502V
Reference
9350
EMDN
W0105050204
EMDN description
ECHINOCOCCUS
First on market country
France
Authorised representative
Leman Diagnostics SARL
Last updated
01.08.2026 10:28
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Acanthocheilonema viteae IgG ELISA

Acanthocheilonema viteae IgG ELISA

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent
Manufacturer
Bordier Affinity Products SA
Manufacturer SRN
CH-MF-000025247
UDI-DI
07640158219409
Basic UDI-DI
76401582194002K
Reference
9400
EMDN
W0105050299
EMDN description
PARASITOLOGY - OTHER
First on market country
France
Authorised representative
Leman Diagnostics SARL
Last updated
01.08.2026 10:28
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Strongyloïdes ratti IgG ELISA

Strongyloides ratti IgG ELISA

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent
Manufacturer
Bordier Affinity Products SA
Manufacturer SRN
CH-MF-000025247
UDI-DI
07640158219454
Basic UDI-DI
764015821945032
Reference
9450
EMDN
W0105050299
EMDN description
PARASITOLOGY - OTHER
First on market country
France
Authorised representative
Leman Diagnostics SARL
Last updated
01.08.2026 10:28
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Leishmania infantum IgG ELISA

Leishmania infantum IgG ELISA

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent
Manufacturer
Bordier Affinity Products SA
Manufacturer SRN
CH-MF-000025247
UDI-DI
07640158219508
Basic UDI-DI
76401582195002Q
Reference
9500
EMDN
W0105050205
EMDN description
LEISHMANIA
First on market country
France
Authorised representative
Leman Diagnostics SARL
Last updated
01.08.2026 10:28
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Entamoeba histolytica IgG ELISA

Entamoeba histolytica IgG ELISA

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent
Manufacturer
Bordier Affinity Products SA
Manufacturer SRN
CH-MF-000025247
UDI-DI
07640158219553
Basic UDI-DI
764015821955037
Reference
9550
EMDN
W0105050201
EMDN description
ENTAMOEBA HISTOLYTICA
First on market country
France
Authorised representative
Leman Diagnostics SARL
Last updated
01.08.2026 10:28
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Schistosoma mansoni IgG ELISA

Schistosoma mansoni IgG ELISA

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent
Manufacturer
Bordier Affinity Products SA
Manufacturer SRN
CH-MF-000025247
UDI-DI
07640158219607
Basic UDI-DI
76401582196002V
Reference
9600
EMDN
W0105050206
EMDN description
SCHISTOSOMA
First on market country
France
Authorised representative
Leman Diagnostics SARL
Last updated
01.08.2026 10:28
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details