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TREN

Last updated

23.09.2026 04:15

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Successful

Device

3540602

Actor

47793

Certificate

3399

Active filter:EMDN:W01050111

241 device results listed.

Page 8 / 13

CSVXML
D-81649002CGBS01AC2NU

CGBS01A-AHG4E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Healgen Life Science LLC
Manufacturer SRN
US-MF-000043017
UDI-DI
D-81649002CGBS01AC2NU
Basic UDI-DI
B-81649002CGBS01AC2NU
Reference
CGBS01A-AHG4E
EMDN
W0105011102
EMDN description
STREPTOCOCCAL DETECTION BY NA REAGENTS
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
12.07.2026 10:04
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-81649002CGBSZK01A7A8A

CGBSZK01A-AHG4E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Healgen Life Science LLC
Manufacturer SRN
US-MF-000043017
UDI-DI
D-81649002CGBSZK01A7A8A
Basic UDI-DI
B-81649002CGBSZK01A7A8A
Reference
CGBSZK01A-AHG4E
EMDN
W0105011102
EMDN description
STREPTOCOCCAL DETECTION BY NA REAGENTS
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
12.07.2026 10:04
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-81649002AGAS01BNG6

AGAS01-AHG48E; AGAS01D-AHG48E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Healgen Scientific Limited Liability Company
Manufacturer SRN
US-MF-000018839
UDI-DI
D-81649002AGAS01BNG6
Basic UDI-DI
B-81649002AGAS01BNG6
Reference
AGAS01-AHG48E; AGAS01D-AHG48E
EMDN
W0105011103
EMDN description
STREP. A DETECTION BY NA REAGENTS
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
12.07.2026 10:00
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-81649002AGAS01DATP8

AGAS01-AHG48E; AGAS01D-AHG48E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Healgen Scientific Limited Liability Company
Manufacturer SRN
US-MF-000018839
UDI-DI
D-81649002AGAS01DATP8
Basic UDI-DI
B-81649002AGAS01DATP8
Reference
AGAS01-AHG48E; AGAS01D-AHG48E
EMDN
W0105011103
EMDN description
STREP. A DETECTION BY NA REAGENTS
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
12.07.2026 09:59
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
mariPOC® Pneumococcus respiratory test reagent

mariPOC® Pneumococcus respiratory test reagent

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent
Manufacturer
ArcDia International Oy Ltd
Manufacturer SRN
FI-MF-000007553
UDI-DI
D-1R11EG
Basic UDI-DI
B-1R11EG
Reference
1R11
EMDN
W0105011101
EMDN description
STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country
Finland
Authorised representative
-
Last updated
11.07.2026 14:26
Manufacturer productsView details
mariPOC® Group A streptococcus test reagent

mariPOC® Group A streptococcus test reagent

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent
Manufacturer
ArcDia International Oy Ltd
Manufacturer SRN
FI-MF-000007553
UDI-DI
D-1R02EF
Basic UDI-DI
B-1R02EF
Reference
1R02
EMDN
W0105011101
EMDN description
STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country
Finland
Authorised representative
-
Last updated
11.07.2026 14:17
Manufacturer productsView details
Sentosa SA Strep A PCR Test (4x8)

300032

IVD generalIVDDOn the marketKitMicrobial substancesReagentSingle use
Manufacturer
Vela Operations Singapore Pte. Ltd.
Manufacturer SRN
SG-MF-000025684
UDI-DI
08885013953091
Basic UDI-DI
B-08885013953091
Reference
300032
EMDN
W0105011103
EMDN description
STREP. A DETECTION BY NA REAGENTS
First on market country
Germany
Authorised representative
Vela Diagnostics Germany GmbH
Last updated
10.07.2026 17:16
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
LyoSens Strep A qPCR Kit

LYO87WS96

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
Vitrosens Biotechnology Inc.
Manufacturer SRN
TR-MF-000026452
UDI-DI
08685115803535
Basic UDI-DI
B-08685115803535
Reference
LYO87
EMDN
W0105011103
EMDN description
STREP. A DETECTION BY NA REAGENTS
First on market country
Germany
Authorised representative
-
Last updated
09.07.2026 06:22
Manufacturer productsView details
RevoDx MRSA qPCR Kit

RevoDx MRSA qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN
TR-MF-000047330
UDI-DI
08684387214391
Basic UDI-DI
B-08684387214391
Reference
IP202266-100
EMDN
W0105011102
EMDN description
STREPTOCOCCAL DETECTION BY NA REAGENTS
First on market country
Austria
Authorised representative
-
Last updated
09.07.2026 02:01
Manufacturer productsView details
RevoDx MRSA qPCR Kit

RevoDx MRSA qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN
TR-MF-000047330
UDI-DI
08684387214384
Basic UDI-DI
B-08684387214384
Reference
IP202266-25
EMDN
W0105011102
EMDN description
STREPTOCOCCAL DETECTION BY NA REAGENTS
First on market country
Austria
Authorised representative
-
Last updated
09.07.2026 02:01
Manufacturer productsView details
RevoDx Streptococcus agalactiae qPCR Kit

RevoDx Streptococcus agalactiae qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN
TR-MF-000047330
UDI-DI
08684387213479
Basic UDI-DI
B-08684387213479
Reference
IP202251-500
EMDN
W0105011104
EMDN description
STREP. B DETECTION BY NA REAGENTS
First on market country
Türkiye
Authorised representative
-
Last updated
09.07.2026 01:57
Manufacturer productsView details
RevoDx Streptococcus pneumoniae qPCR Kit

RevoDx Streptococcus pneumoniae qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN
TR-MF-000047330
UDI-DI
08684387213295
Basic UDI-DI
B-08684387213295
Reference
IP202214-500
EMDN
W0105011105
EMDN description
STREP. PNEUMONIAE DETECTION BY NA REAGENTS
First on market country
Türkiye
Authorised representative
-
Last updated
09.07.2026 01:56
Manufacturer productsView details
RevoDx Staphyloccocus spp. qPCR Kit

RevoDx Staphyloccocus spp. qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN
TR-MF-000047330
UDI-DI
08684387213264
Basic UDI-DI
B-08684387213264
Reference
IP202209-500
EMDN
W0105011102
EMDN description
STREPTOCOCCAL DETECTION BY NA REAGENTS
First on market country
Türkiye
Authorised representative
-
Last updated
09.07.2026 01:56
Manufacturer productsView details
RevoDx Staphyloccocus aureus qPCR Kit

RevoDx Staphyloccocus aureus qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN
TR-MF-000047330
UDI-DI
08684387213257
Basic UDI-DI
B-08684387213257
Reference
IP202208-25
EMDN
W0105011102
EMDN description
STREPTOCOCCAL DETECTION BY NA REAGENTS
First on market country
Türkiye
Authorised representative
-
Last updated
09.07.2026 01:56
Manufacturer productsView details
RevoDx Streptococcus pneumoniae / pyogenes / agalactiae qPCR Kit

RevoDx Streptococcus pneumoniae / pyogenes / agalactiae qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN
TR-MF-000047330
UDI-DI
08684387212892
Basic UDI-DI
B-08684387212892
Reference
IP202427-100
EMDN
W0105011102
EMDN description
STREPTOCOCCAL DETECTION BY NA REAGENTS
First on market country
Türkiye
Authorised representative
-
Last updated
09.07.2026 01:55
Manufacturer productsView details
RevoDx Streptococcus pyogenes qPCR Kit

RevoDx Streptococcus pyogenes qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN
TR-MF-000047330
UDI-DI
08684387212571
Basic UDI-DI
B-08684387212571
Reference
IP202313-100
EMDN
W0105011103
EMDN description
STREP. A DETECTION BY NA REAGENTS
First on market country
Türkiye
Authorised representative
-
Last updated
09.07.2026 01:54
Manufacturer productsView details
RevoDx Streptococcus pyogenes qPCR Kit

RevoDx Streptococcus pyogenes qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN
TR-MF-000047330
UDI-DI
08684387212564
Basic UDI-DI
B-08684387212564
Reference
IP202313-25
EMDN
W0105011103
EMDN description
STREP. A DETECTION BY NA REAGENTS
First on market country
Türkiye
Authorised representative
-
Last updated
09.07.2026 01:54
Manufacturer productsView details
ChainFor Strep A qPCR Kit

CFP50P100

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitProfessional testingReagent
Manufacturer
Vitrosens Biotechnology Inc.
Manufacturer SRN
TR-MF-000026452
UDI-DI
08683548259189
Basic UDI-DI
B-08683548259189
Reference
CFP50
EMDN
W0105011103
EMDN description
STREP. A DETECTION BY NA REAGENTS
First on market country
Germany
Authorised representative
-
Last updated
09.07.2026 00:20
Manufacturer productsView details
Xpert®

Xpert® GBS

IVD generalIVDDNo longer on the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Cepheid
Manufacturer SRN
US-MF-000010979
UDI-DI
D-07332940000127FC
Basic UDI-DI
B-07332940000127FC
Reference
GXGBS-100N-10
EMDN
W0105011104
EMDN description
STREP. B DETECTION BY NA REAGENTS
First on market country
Netherlands
Authorised representative
Cepheid AB
Last updated
07.07.2026 04:14
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Xpert®

Xpert® Xpress Strep A

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Cepheid
Manufacturer SRN
US-MF-000010979
UDI-DI
07332940006297
Basic UDI-DI
B-07332940006297
Reference
XPRSTREPA-CE-10
EMDN
W0105011103
EMDN description
STREP. A DETECTION BY NA REAGENTS
First on market country
Netherlands
Authorised representative
Cepheid AB
Last updated
07.07.2026 04:06
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details