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Public EUDAMED Search

EUDAMED Device Search

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

TREN

Last updated

14.10.2026 10:12

Sync status

Successful

Device

4139381

Actor

48059

Certificate

3479

Active filter:Manufacturer SRN:US-MF-000001646

99 device results listed.

Page 5 / 5

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

-

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
Aptima Urine Specimen Collection Kit for Male and Female Urine Specimens

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IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use
Manufacturer
Hologic
Manufacturer SRN
US-MF-000001646
UDI-DI
25420045506265
Basic UDI-DI
54200455DIAGCOLLECTVT
Reference
301040
EMDN
W050299
EMDN description
DEVICES FOR SAMPLES TRANSPORT - OTHER
First on market country
-
Authorised representative
Hologic BV
Last updated
24.06.2026 06:41
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Aptima Unisex Swab Specimen Collection Kit for Endocervical and Male Urethral Swab Specimens

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IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use
Manufacturer
Hologic
Manufacturer SRN
US-MF-000001646
UDI-DI
25420045506272
Basic UDI-DI
54200455DIAGCOLLECTVT
Reference
301041
EMDN
W050299
EMDN description
DEVICES FOR SAMPLES TRANSPORT - OTHER
First on market country
-
Authorised representative
Hologic BV
Last updated
24.06.2026 06:41
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Aptima HPV 16 18/45 Genotype Assay Calibrators Kit

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IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use
Manufacturer
Hologic
Manufacturer SRN
US-MF-000001646
UDI-DI
15420045500136
Basic UDI-DI
54200455DIAGAPTHPVGTVK
Reference
303235
EMDN
W0105041003
EMDN description
PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country
-
Authorised representative
Hologic BV
Last updated
16.06.2026 18:39
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Aptima Mycoplasma genitalium Assay Calibrators Kit

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IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use
Manufacturer
Hologic
Manufacturer SRN
US-MF-000001646
UDI-DI
15420045509160
Basic UDI-DI
54200455DIAGAPTMGENY9
Reference
PRD-03393
EMDN
W010501080302
EMDN description
UROGENITAL MYCOPLASMA DETECTION BY NA REAGENTS
First on market country
-
Authorised representative
Hologic BV
Last updated
16.06.2026 18:39
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Aptima CV/TV Assay Calibrator

-

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