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SMI

www.sutures.be

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, United Kingdom, Australia, Israel — 4 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

0UDI-DI device records

USUnited StatesFDA openFDA

1510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

4registered device records

Class IIb 3Class III 1

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

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

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

8active ARTG entries

Class I 1Class III 3IIa 3IIb 1

HKHong KongMDACS

pendingnot queried

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.

European Union2,610 raw hits, 300 excluded, 0 confirmed. Large result set — only the first 300 verified

United States0 registration records, 1 510(k), 0 PMA, 4 excluded

United Kingdom4 confirmed, 105 excluded

Regulatory identity

UK responsible person: Regen Marketing Limited
Exhibition record: CMEF 93rd (Apr 2026, Shanghai)

Market	Identifier	Name	Class / date
UK	17471	PGA POLYGLYCOLIC ACID PGA RAPID POLYGLYCOLIC ACID	Class III
UK	13906	POLYESTER	Class IIb
UK	13909	POLYPROPYLENE	Class IIb
US	K931261	SPECTROPAD SYSTEM	1994-03-31

SMI

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

Registration details (sample)

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