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ANIKA THERAPEUTICS, INC.

USA · Bedford

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 9 overseas markets. The China NMPA lookup is still pending.

Registrations by market

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

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

11listed device types

Class I 1Class II 4Class III 5unclassified 1

plus 15 registration records and 9 510(k), 90 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

2 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

3active device licences

Class III 1Class IV 2

11 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

3device registrations

CLASS D 2D WITH MEDICINAL PRODUCT 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

2active ARTG entries

Class III 2

HKHong KongMDACS

4valid listings

Class IV 4

ILIsraelAMAR

5registrations

RURussiaRoszdravnadzor

1active registrations

Class 3 1

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.

United States15 registration records, 9 510(k), 90 PMA

Canada3 confirmed, 0 excluded

Manufacturer names merged into this page: ANIKA THERAPEUTICS, INC. · ANIKA THERAPEUTICS INC · ANIKA THERAPEUTICS S.R.L. · ANIKA THERAPEUTICS INC.

Business registration

CIK: 0000898437
Registration status: Active
Listing status: Listed (ANIK)

Business registration data from SEC EDGAR, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

12017

12020 · K190956

12021 · K212083

52023 · K231968

12025 · K250997

FDA listed device types

showing 8 of 11

Aid, Surgical, Viscoelastic 1Implant, Dermal, For Aesthetic Use 1Inhibitor, Peridural Fibrosis (Adhesion Barrier) 1Barrier, Absorbable, Adhesion 1Acid, Hyaluronic, Intraarticular 1Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon 1Filler, Bone Void, Calcium Compound 1Fastener, Fixation, Nondegradable, Soft Tissue 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K250997	Integrity Implant	2025-06-17
US	K231968	Tactoset® Injectable Bone Substitute	2023-12-20
US	K223538	Integrity Implant	2023-08-17
CA	62199	COEASE SODIUM HYALURONATE	Class IV
CA	73021	ELEVESS	Class III
CA	64655	MEROGEL INJECTABLE	Class IV