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Home›Italy›ANIKA THERAPEUTICS S.R.L.

ANIKA THERAPEUTICS S.R.L.

Italy · Padova
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel — 8 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
2valid device licences
Class III 2
SGSingaporeHSA SMDR
1device registrations
CLASS D 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
5active ARTG entries
Class I 5
HKHong KongMDACS
1valid listings
Class IV 1
ILIsraelAMAR
2registrations
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.

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.
Same-named companies — This database also contains companies with near-identical names: ANIKA THERAPEUTICS, INC.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Italy
City
Padova

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

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)

MarketIdentifierNameClass / date
USK250997Integrity™ Implant2025-06-17
USK231968Tactoset® Injectable Bone Substitute2023-12-20
USK223538Integrity Implant2023-08-17
CA62199COEASE SODIUM HYALURONATEClass IV
CA73021ELEVESSClass III
CA64655MEROGEL INJECTABLEClass IV

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