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Assut Europe S.p.A.

✓ Record-verifiedregistrations found in 9 marketsEU SRN IT-MF-000018178

This company has registrations in European Union, United States, United Kingdom, Brazil, Singapore, Australia, Hong Kong, Israel, Russia — 9 overseas markets. EU UDI-DI records ≥100, the first 300 verified individually. 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

≥100UDI-DI device records

Class III 100

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

4listed device types

Class I 0Class II 4Class III 0

plus 6 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

26registered device records

Class IIb 1Class III 24System or Procedure Pack 1

BRBrazilANVISA

7registered devices

Class I 1Class II 6

42 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

1device registrations

CLASS D 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

4active ARTG entries

Class III 4

HKHong KongMDACS

21valid listings

Class IV 21

ILIsraelAMAR

10registrations

RURussiaRoszdravnadzor

4active registrations

Class 3 4

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 Union9,077 raw hits, 0 excluded, 100 confirmed. Large result set — only the first 300 verified

United States6 registration records, 3 510(k), 0 PMA

United Kingdom26 confirmed, 0 excluded

Brazil7 confirmed, 0 excluded

Manufacturer names merged into this page: Assut Europe S.P.A. · ASSUT EUROPE S.P.A · ASSUT EUROPE LATINO AMERICA IMPORTAÇÃO E EXPORTAÇÃO LTDA · ASSUT EUROPE SPA · ASSUT EUROPE

Regulatory identity

EU manufacturer SRN: IT-MF-000018178
UK responsible person: Assut UK Ltd

Business registration

LEI: 9845005G7445612AF811
Registration status: Active
Legal form: Società Per Azioni (SPA)
Incorporated: 1990-10-30
Registered address: VIA GIUSEPPE GREGORACI 12, ROMA, 00173
Registration authority: Business Register, no. 01262470667
Registry record updated: 2026-02-03

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

FDA 510(k) clearances by year

12002 · K021767

12016 · K150553

12017 · K171039

FDA listed device types

Suture, Surgical, Absorbable, Polydioxanone 1Suture, Absorbable, Synthetic, Polyglycolic Acid 1Endoscopic Tissue Approximation Device 1Suture, Nonabsorbable, Synthetic, Polypropylene 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	38033439463095	SUTRON	Class III
EU	18033439432714	NYLON	Class III
EU	38033439463088	SUTRON	Class III
EU	18033439432745	NYLON	Class III
UK	60480	FILBLOC	Class III
UK	60480	FILBLOC 90	Class III
UK	60480	FILBLOC PDO	Class III
US	K171039	Assut Filbloc Permanent Sutures	2017-08-29
US	K150553	Filbloc	2016-05-19
US	K021767	ASSUFIL	2002-11-19
BR	80262289002	Anuscópio Descartável Sylarum	Class II
BR	80262280019	Trocater X-ONE com Lâmina Plana	Class II
BR	80262280020	Trocater X-ONE	Class II