Public EUDAMED Search

EUDAMED Device Search

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

Last updated

22.09.2026 16:13

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Successful

Device

3537745

Actor

47762

Certificate

3388

Active filter:EMDN:W0105094001

108 device results listed.

Page 4 / 6

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use
Manufacturer
Healgen Scientific Limited Liability Company
Manufacturer SRN
US-MF-000018839
UDI-DI
D-GCCOV(Ag)-PN20HG4Y
Basic UDI-DI
B-GCCOV(Ag)-PN20HG4Y
Reference
GCCOV(Ag)-PN20
EMDN
W0105094001
EMDN description
CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
14.07.2026 00:23
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use
Manufacturer
Healgen Scientific Limited Liability Company
Manufacturer SRN
US-MF-000018839
UDI-DI
D-GCCOV(Ag)-PN10HG4R
Basic UDI-DI
B-GCCOV(Ag)-PN10HG4R
Reference
GCCOV(Ag)-PN10
EMDN
W0105094001
EMDN description
CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
14.07.2026 00:23
biotical E. Coli Positive control (1u)

biotical E. Coli Positive control (1u) / 1 control positivo E. Coli O157:H7 (sin test rápido)

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use
Manufacturer
BIOTICAL HEALTH S.L.U
Manufacturer SRN
ES-MF-000018831
UDI-DI
84365942157598
Basic UDI-DI
B-84365942157598
Reference
CPRT01E
EMDN
W0105094001
EMDN description
CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country
Spain
Authorised representative
-
Last updated
12.07.2026 10:13
biotical Crypto Positive control (30u)

biotical Crypto Positive control (30u) / 30 controles positivos Crypto (sin test rápido)

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use
Manufacturer
BIOTICAL HEALTH S.L.U
Manufacturer SRN
ES-MF-000018831
UDI-DI
84365942153224
Basic UDI-DI
B-84365942153224
Reference
CPRT30K
EMDN
W0105094001
EMDN description
CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country
Spain
Authorised representative
-
Last updated
12.07.2026 10:13
1 control positivo Giardia (sin test rápido)

biotical Giardia Positive control (1u) / 1 control positivo Giardia (sin test rápido)

IVD generalIVDDOn the marketAnimal tissuesProfessional testingSingle use
Manufacturer
BIOTICAL HEALTH S.L.U
Manufacturer SRN
ES-MF-000018831
UDI-DI
84365942152852
Basic UDI-DI
B-84365942152852
Reference
CPRT01G
EMDN
W0105094001
EMDN description
CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country
Spain
Authorised representative
-
Last updated
12.07.2026 10:12
biotical Giardia Positive control (30u)

biotical Giardia Positive control (30u) /

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use
Manufacturer
BIOTICAL HEALTH S.L.U
Manufacturer SRN
ES-MF-000018831
UDI-DI
84365942152784
Basic UDI-DI
B-84365942152784
Reference
CPRT30G
EMDN
W0105094001
EMDN description
CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country
Spain
Authorised representative
-
Last updated
12.07.2026 10:12
biotical Y. enterocolitica O:3 Positive control (30u)

biotical Y. enterocolitica O:3 Positive control (30u) / 30 controles positivos Yersinia enterocolitica O:3 (sin test rápido)

IVD generalIVDDOn the marketAnimal tissuesReagentSingle use
Manufacturer
BIOTICAL HEALTH S.L.U
Manufacturer SRN
ES-MF-000018831
UDI-DI
84365942152234
Basic UDI-DI
B-84365942152234
Reference
CPRT30Y3
EMDN
W0105094001
EMDN description
CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country
Spain
Authorised representative
-
Last updated
12.07.2026 10:12
biotical Y. enterocolitica O:3 Positive control (1u)

biotical Y. enterocolitica O:3 Positive control (1u) / 1 control positivo Yersinia enterocolitica O:3 (sin test rápido)

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use
Manufacturer
BIOTICAL HEALTH S.L.U
Manufacturer SRN
ES-MF-000018831
UDI-DI
84365942152302
Basic UDI-DI
B-84365942152302
Reference
CPRT01Y3
EMDN
W0105094001
EMDN description
CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country
Spain
Authorised representative
-
Last updated
12.07.2026 10:12
1 control positivo Yersinia enterocolitica O:9 (sin test rápido)

biotical Y. enterocolitica O:9 Positive control (1u) / 1 control positivo Yersinia enterocolitica O:9 (sin test rápido)

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use
Manufacturer
BIOTICAL HEALTH S.L.U
Manufacturer SRN
ES-MF-000018831
UDI-DI
84365942151862
Basic UDI-DI
B-84365942151862
Reference
CPRT01Y9
EMDN
W0105094001
EMDN description
CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country
Spain
Authorised representative
-
Last updated
12.07.2026 10:12
biotical Y. enterocolitica O:9 Positive control (30u)

biotical Y. enterocolitica O:9 Positive control (30u) / 30 controles positivos Yersinia enterocolitica O:9 (sin test rápido)

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use
Manufacturer
BIOTICAL HEALTH S.L.U
Manufacturer SRN
ES-MF-000018831
UDI-DI
84365942151794
Basic UDI-DI
B-84365942151794
Reference
CPRT30Y9
EMDN
W0105094001
EMDN description
CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country
Spain
Authorised representative
-
Last updated
12.07.2026 10:12
biotical C. difficile Toxin B Positive control (1u)

biotical C. difficile Toxin B Positive control (1u) /

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use
Manufacturer
BIOTICAL HEALTH S.L.U
Manufacturer SRN
ES-MF-000018831
UDI-DI
84365942151312
Basic UDI-DI
B-84365942151312
Reference
CPRT01TB
EMDN
W0105094001
EMDN description
CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country
Spain
Authorised representative
-
Last updated
12.07.2026 10:12
biotical C. difficile Toxin B Positive control (30u)

biotical C. difficile Toxin B Positive control (30u) / 30 controles positivos C. difficile Toxins B (sin test rápido)

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use
Manufacturer
BIOTICAL HEALTH S.L.U
Manufacturer SRN
ES-MF-000018831
UDI-DI
84365942151244
Basic UDI-DI
B-84365942151244
Reference
CPRT30TB
EMDN
W0105094001
EMDN description
CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country
Spain
Authorised representative
-
Last updated
12.07.2026 10:12
biotical C. difficile Toxin A Positive control (1u)

biotical C. difficile Toxin A Positive control (1u) / 1 control positivo C. difficile Toxins A (sin test rápido)

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use
Manufacturer
BIOTICAL HEALTH S.L.U
Manufacturer SRN
ES-MF-000018831
UDI-DI
84365942151176
Basic UDI-DI
B-84365942151176
Reference
CPRT01TA
EMDN
W0105094001
EMDN description
CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country
Spain
Authorised representative
-
Last updated
12.07.2026 10:12
biotical C. difficile Toxin A Positive control (30u)

biotical C. difficile Toxin A Positive control (30u) / 30 controles positivos C. difficile Toxins A (sin test rápido)

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use
Manufacturer
BIOTICAL HEALTH S.L.U
Manufacturer SRN
ES-MF-000018831
UDI-DI
84365942151008
Basic UDI-DI
B-84365942151008
Reference
CPRT30TA
EMDN
W0105094001
EMDN description
CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country
Spain
Authorised representative
-
Last updated
12.07.2026 10:12
biotical C. difficile GDH Positive control (1u)

biotical C. difficile GDH Positive control (1u) / 1 control positivo C. difficile GDH (sin test rápido)

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use
Manufacturer
BIOTICAL HEALTH S.L.U
Manufacturer SRN
ES-MF-000018831
UDI-DI
84365942150636
Basic UDI-DI
B-84365942150636
Reference
CPRT01GD
EMDN
W0105094001
EMDN description
CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country
Spain
Authorised representative
-
Last updated
12.07.2026 10:12
biotical C. difficile GDH Positive control (30u)

biotical C. difficile GDH Positive control (30u) /

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use
Manufacturer
BIOTICAL HEALTH S.L.U
Manufacturer SRN
ES-MF-000018831
UDI-DI
84365942150568
Basic UDI-DI
B-84365942150568
Reference
CPRT30GD
EMDN
W0105094001
EMDN description
CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country
Spain
Authorised representative
-
Last updated
12.07.2026 10:12
biotical H. pylori Positive control (1u)

biotical H. pylori Positive control (1u) / 1 control positivo H. pylori (sin test rápido)

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use
Manufacturer
BIOTICAL HEALTH S.L.U
Manufacturer SRN
ES-MF-000018831
UDI-DI
84365942150186
Basic UDI-DI
B-84365942150186
Reference
CPRT01PG
EMDN
W0105094001
EMDN description
CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country
Spain
Authorised representative
-
Last updated
12.07.2026 10:12
biotical S. paratyphi Positive control (1u)

biotical S. paratyphi Positive control (1u) / 1 unidad de hisopo de control positivo Salmonella paratyphi.

IVD generalIVDDOn the marketAnimal tissuesProfessional testingSingle use
Manufacturer
BIOTICAL HEALTH S.L.U
Manufacturer SRN
ES-MF-000018831
UDI-DI
84365942149128
Basic UDI-DI
B-84365942149128
Reference
CPRT01SP
EMDN
W0105094001
EMDN description
CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country
Spain
Authorised representative
-
Last updated
12.07.2026 10:04
biotical S. paratyphi Positive control (30u)

biotical S. paratyphi Positive control (30u) / 30 controles positivos Salmonella paratyphi (sin test rápido)

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use
Manufacturer
BIOTICAL HEALTH S.L.U
Manufacturer SRN
ES-MF-000018831
UDI-DI
84365942149050
Basic UDI-DI
B-84365942149050
Reference
CPRT30SP
EMDN
W0105094001
EMDN description
CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country
Spain
Authorised representative
-
Last updated
12.07.2026 10:04
biotical Salmonella Positive control (1u)

biotical Salmonella Positive control (1u) / 1 control positivo Salmonella (sin test rápido)

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use
Manufacturer
BIOTICAL HEALTH S.L.U
Manufacturer SRN
ES-MF-000018831
UDI-DI
84365942148688
Basic UDI-DI
B-84365942148688
Reference
CPRT01SA
EMDN
W0105094001
EMDN description
CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country
Spain
Authorised representative
-
Last updated
12.07.2026 10:04