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TREN

Last updated

01.08.2026 16:25

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Successful

Device

2989409

Actor

47522

Certificate

3174

Active filter:EMDN:W0105070501

219 device results listed.

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Aptima Combo 2 Assay

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IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use
Manufacturer
Hologic
Manufacturer SRN
US-MF-000001646
UDI-DI
15420045512849
Basic UDI-DI
54200455DIAGAPTCOMBO2P8
Reference
PRD-05571
EMDN
W0105070501
EMDN description
STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country
-
Authorised representative
Hologic BV
Last updated
29.06.2026 22:47
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Aptima Combo 2 Assay

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IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use
Manufacturer
Hologic
Manufacturer SRN
US-MF-000001646
UDI-DI
15420045512894
Basic UDI-DI
54200455DIAGAPTCOMBO2P8
Reference
PRD-05576
EMDN
W0105070501
EMDN description
STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country
-
Authorised representative
Hologic BV
Last updated
29.06.2026 22:47
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Aptima CV/TV Assay

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IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use
Manufacturer
Hologic
Manufacturer SRN
US-MF-000001646
UDI-DI
15420045512078
Basic UDI-DI
54200455DIAGAPTCVTV2E
Reference
PRD-05189
EMDN
W0105070501
EMDN description
STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country
-
Authorised representative
Hologic BV
Last updated
29.06.2026 13:22
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Aptima CV/TV Assay Controls Kit

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IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use
Manufacturer
Hologic
Manufacturer SRN
US-MF-000001646
UDI-DI
15420045512092
Basic UDI-DI
54200455DIAGAPTCVTV2E
Reference
PRD-05190
EMDN
W0105070501
EMDN description
STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country
-
Authorised representative
Hologic BV
Last updated
29.06.2026 13:22
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Aptima CV/TV Assay

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IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use
Manufacturer
Hologic
Manufacturer SRN
US-MF-000001646
UDI-DI
15420045517073
Basic UDI-DI
54200455DIAGAPTCVTV2E
Reference
PRD-07665
EMDN
W0105070501
EMDN description
STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country
-
Authorised representative
Hologic BV
Last updated
29.06.2026 13:22
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Aptima CV/TV Assay

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IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use
Manufacturer
Hologic
Manufacturer SRN
US-MF-000001646
UDI-DI
15420045517080
Basic UDI-DI
54200455DIAGAPTCVTV2E
Reference
PRD-07665
EMDN
W0105070501
EMDN description
STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country
-
Authorised representative
Hologic BV
Last updated
29.06.2026 13:22
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
TRUPCR® STD Panel Kit

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IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent
Manufacturer
3B BlackBio Dx Limited
Manufacturer SRN
IN-MF-000023698
UDI-DI
08908015304927
Basic UDI-DI
89080153043B291NQ
Reference
3B291
EMDN
W0105070501
EMDN description
STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country
-
Authorised representative
Wellkang Ltd
Last updated
29.06.2026 11:20
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
TRUPCR® STD Panel Kit

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IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent
Manufacturer
3B BlackBio Dx Limited
Manufacturer SRN
IN-MF-000023698
UDI-DI
08908015304934
Basic UDI-DI
89080153043B291NQ
Reference
3B292
EMDN
W0105070501
EMDN description
STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country
-
Authorised representative
Wellkang Ltd
Last updated
29.06.2026 11:20
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Chlamydia Trachomatis/Ureaplasma Urealyticum/Neisseria Gonorrhoeae DNA Diagnostic Kit (PCR-Fluorescence Probing)

Chlamydia Trachomatis/Ureaplasma Urealyticum/Neisseria Gonorrhoeae DNA Diagnostic Kit (PCR-Fluorescence Probing)

IVD Annex II List BIVDDOn the marketKitMicrobial substancesProfessional testingReagent
Manufacturer
Sansure Biotech Inc.
Manufacturer SRN
CN-MF-000011392
UDI-DI
06955792731103
Basic UDI-DI
B-06955792731103
Reference
S3050E
EMDN
W0105070501
EMDN description
STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country
Italy
Authorised representative
Obelis s.a.
Last updated
28.06.2026 20:29
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
BIOSYNEX AMPLIQUICK STI Panel I

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IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
BIOSYNEX
Manufacturer SRN
FR-MF-000014073
UDI-DI
03532670103585
Basic UDI-DI
353267F00204P7T
Reference
3150070_SEC02
EMDN
W0105070501
EMDN description
STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country
-
Authorised representative
-
Last updated
28.06.2026 11:40
Manufacturer productsView details
BIOSYNEX AMPLIQUICK STI Panel I

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IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
BIOSYNEX
Manufacturer SRN
FR-MF-000014073
UDI-DI
03532670103592
Basic UDI-DI
353267F00204P7T
Reference
3150070_BLK100
EMDN
W0105070501
EMDN description
STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country
-
Authorised representative
-
Last updated
28.06.2026 11:40
Manufacturer productsView details
Nucleic Acid Detection Kit for Reproductive Tract Infection Pathogens (9 Types)(Flowcytometry Fluorescence Hybridization Method)

Nucleic Acid Detection Kit for Reproductive Tract Infection Pathogens (9 Types)(Flowcytometry Fluorescence Hybridization Method)

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN
CN-MF-000017965
UDI-DI
06950996004510
Basic UDI-DI
B-06950996004510
Reference
2RET9A11
EMDN
W0105070501
EMDN description
STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country
Ireland
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
28.06.2026 09:33
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Alinity m

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IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Abbott Molecular Inc.
Manufacturer SRN
US-MF-000017776
UDI-DI
00884999047945
Basic UDI-DI
0884999AMN0917XS
Reference
09N17-090
EMDN
W0105070501
EMDN description
STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country
-
Authorised representative
Abbott GmbH
Last updated
19.06.2026 22:48
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
PlexPCR VHS(610)

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IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent
Manufacturer
SpeeDx Pty. Ltd.
Manufacturer SRN
AU-MF-000016649
UDI-DI
09352224000146
Basic UDI-DI
9352224011210WD
Reference
1121001
EMDN
W0105070501
EMDN description
STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country
-
Authorised representative
MedEnvoy Global BV
Last updated
17.06.2026 00:08
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
PlexPCR VHS(675)

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IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent
Manufacturer
SpeeDx Pty. Ltd.
Manufacturer SRN
AU-MF-000016649
UDI-DI
09352224000153
Basic UDI-DI
9352224011210WD
Reference
1125001
EMDN
W0105070501
EMDN description
STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country
-
Authorised representative
MedEnvoy Global BV
Last updated
17.06.2026 00:08
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
PlexPCR VHS (7500)

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IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent
Manufacturer
SpeeDx Pty. Ltd.
Manufacturer SRN
AU-MF-000016649
UDI-DI
09352224001310
Basic UDI-DI
9352224011210WD
Reference
99004
EMDN
W0105070501
EMDN description
STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country
-
Authorised representative
MedEnvoy Global BV
Last updated
17.06.2026 00:08
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
PLexPCR VHS (LC480)

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IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent
Manufacturer
SpeeDx Pty. Ltd.
Manufacturer SRN
AU-MF-000016649
UDI-DI
09352224001327
Basic UDI-DI
9352224011210WD
Reference
99005
EMDN
W0105070501
EMDN description
STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country
-
Authorised representative
MedEnvoy Global BV
Last updated
17.06.2026 00:08
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
PlexPCR VHS (CFX)

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IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent
Manufacturer
SpeeDx Pty. Ltd.
Manufacturer SRN
AU-MF-000016649
UDI-DI
09352224001334
Basic UDI-DI
9352224011210WD
Reference
99006
EMDN
W0105070501
EMDN description
STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country
-
Authorised representative
MedEnvoy Global BV
Last updated
17.06.2026 00:08
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Aptima CV/TV Assay Calibrator

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IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use
Manufacturer
Hologic
Manufacturer SRN
US-MF-000001646
UDI-DI
15420045512085
Basic UDI-DI
54200455DIAGAPTCVTV2E
Reference
PRD-05191
EMDN
W0105070501
EMDN description
STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country
-
Authorised representative
Hologic BV
Last updated
16.06.2026 18:39
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details