HOLOGIC

✓ Record-verifiedregistrations found in 11 marketsEU SRN US-MF-000001646Unified social credit code 91310115MA1K43GJ4H

This company has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong — 11 overseas markets. No China NMPA registrations were found.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

0China registrations

as of 2026-09-01

EUEuropean UnionEUDAMED

226UDI-DI device records

Class I 39Class IIa 61Class IIb 12IVD A 50IVD B 18IVD C 46

USUnited StatesFDA openFDA

89listed device types

Class I 34Class II 46Class III 7unclassified 2

plus 201 registration records and 119 510(k), 344 PMA

UKUnited KingdomMHRA PARD

212registered device records

Class I 20Class IIa 18Class IIb 16Class III 2IVD A 33IVD B 9IVD C 32IVD D 6IVD general 66IVD Annex II List A 10

BRBrazilANVISA

42registered devices

Class I 34Class II 8

55 including historic records

SASaudi ArabiaSFDA

1registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

82active device licences

Class II 41Class III 38Class IV 3

169 including historic records

TWTaiwanTFDA

36valid device licences

Class I 6Class II 22Class III 8

SGSingaporeHSA SMDR

27device registrations

CLASS B 8CLASS C 17CLASS D 2

KRSouth KoreaMFDS GMP

9GMP quality-system certificates

Business type not stated 1Import 4IVD import 4

AUAustraliaTGA ARTG

75active ARTG entries

Class I 9Class III 3IVD Class 1 7IVD Class 2 6IVD Class 3 16IVD Class 4 6IIa 8IIb 15Class Is (sterile) 5

HKHong KongMDACS

26valid listings

Class II 4Class III 7IVD C 12IVD D 3

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union226 raw hits, 0 excluded, 226 confirmed

United States201 registration records, 119 510(k), 344 PMA, 4 excluded

China0 certificates (Class III 0 / II 0 / I 0), as of 2026-09-01

United Kingdom212 confirmed, 1 excluded

Brazil42 confirmed, 1 excluded

Saudi Arabia1 confirmed, 0 excluded

Canada82 confirmed, 0 excluded

Manufacturer names merged into this page: HOLOGIC, INC. · Hologic, Inc. · HOLOGIC INC. · HOLOGIC, INC · HOLOGIC INC

Regulatory identity

EU manufacturer SRN: US-MF-000001646
EU authorised representative: Hologic BV
UK responsible person: Hologic Ltd.
Unified social credit code: 91310115MA1K43GJ4H
Exhibition record: CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Business registration

Registration status: Active
Incorporated: 2018-05-18
Registered capital: CNY 2,000,000
Paid-in capital: CNY 2,000,000
Legal form: Limited liability company (wholly owned by a foreign-invested enterprise)
Industry classification: Wholesale trade
Last approval date: 2024-12-26
Recognitions: Micro and small enterprise

Business registration data from Tianyancha, as of 2026-09-03. Public registry information only; legal representative and contact-person details are not collected. The figure is the number of employees enrolled in social insurance as declared by the company, which may differ from actual headcount.

FDA 510(k) clearances by year

32006

12007

42008

32009

22010

82011

92012

62013

32014

42015

22016

72017

62018

82019

42020

22022

52023

72024

52025

22026

FDA listed device types

showing 8 of 89

Electrosurgical, Cutting & Coagulation & Accessories 1Densitometer, Bone 1Cytomegalovirus (Cmv) Dna Quantitative Assay 1Cabinet, X-Ray System 1Coagulator, Laparoscopic, Unipolar (And Accessories) 1Needle, Hypodermic, Single Lumen 1Marker, Radiographic, Implantable 1Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	25420045514345	Hologic Direct Load Capture Cap Collection Kits – CLASSIQSwabs	IVD A
EU	25420045515687	RespDirect Collection Kit	IVD A
EU	25420045510187	Aptima Multitest Swab Specimen Collection Kit	IVD A
EU	15420045500280	Aptima Assay Fluids	IVD A
UK	37661	HORIZON BONE DENSITOMETRY SYSTEM	Class IIb
UK	36190	Affirm Lateral Arm	Class I
UK	36190	AFFIRM PRONE BIOPSY SYSTEM, 2D	Class IIb
US	K262792	Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)	2026-08-12
US	K253634	CoolSeal Generator® (CSL-200-90)	2026-06-17
US	K251993	Panther Fusion GI Expanded Bacterial Assay	2025-09-25
BR	10237610019	ESCOVA CERVICAL KOLPLAST	Class I
BR	10237610060	IMAGIN SYSTEM	Class II
BR	80047300522	TRIDENT SPECIMEN RADIOGRAPHY SYSTEM	Class I
SA	ME0000000959SFDAA00060	ATEC	—
CA	36088	QDR 4000 BONE DENSITOMETER	Class III
CA	38895	EPEX SYSTEM	Class III
CA	39212	RADEX SYSTEM	Class III