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PETERS SURGICAL

France · Bobigny

✓ Record-verifiedregistrations found in 11 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 11 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

9listed device types

Class I 3Class II 6Class III 0

plus 22 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

2 including historic records

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

0active device licences

9 including historic records

TWTaiwanTFDA

2valid device licences

Class II 2

SGSingaporeHSA SMDR

1device registrations

CLASS D 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

14active ARTG entries

Class I 1Class III 5IIa 3IIb 4Class Is (sterile) 1

HKHong KongMDACS

1valid listings

Class IV 1

ILIsraelAMAR

14registrations

RURussiaRoszdravnadzor

2active registrations

Class 3 2

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 States22 registration records, 7 510(k), 0 PMA

Brazil1 confirmed, 0 excluded

Saudi Arabia1 confirmed, 1 excluded

Manufacturer names merged into this page: PETERS SURGICAL · PETERS SURGICAL INTERNATIONAL CO., LTD · PÉTERS SURGICAL S.A.S · PÉTERS SURGICAL · Peters Surgical

FDA 510(k) clearances by year

12005 · K052701

22006 · K060163

22007 · K071281

22024 · K233265

FDA listed device types

showing 8 of 9

Suture, Nonabsorbable, Synthetic, Polypropylene 1Suture, Nonabsorbable, Synthetic, Polyethylene 1Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile 1Suture, Absorbable, Synthetic, Polyglycolic Acid 1Suture, Nonabsorbable, Synthetic, Polyamide 1Clip, Implantable 1Applier, Hemostatic Clip 1Snare, Surgical 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K233265	Monotime and Optime R	2024-10-11
US	K232372	Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME)	2024-07-12
US	K071281	UNIRING - ANNULOPLASTY RING WITH SIZERS	2007-08-03
BR	10230390045	Clips/Clamps de Oclusão Temporária	Class II
SA	ME0000000646SFDAA00001	Applier for VITALITEC®	—