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UNILENE S.A.C.

Peru · Lima

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 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 5Class II 6Class III 0

plus 7 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class II 3

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

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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 States7 registration records, 2 510(k), 0 PMA

Brazil3 confirmed, 0 excluded

Manufacturer names merged into this page: UNILENE, SAC · UNILENE S.A.C.

FDA 510(k) clearances by year

12010 · K100780

12013 · K123034

FDA listed device types

showing 8 of 11

Suture, Surgical, Absorbable, Polydioxanone 1Suture, Nonabsorbable, Synthetic, Polypropylene 1Suture, Absorbable, Synthetic 1Suture, Nonabsorbable, Silk 1Suture, Absorbable, Synthetic, Polyglycolic Acid 1Suture, Nonabsorbable, Synthetic, Polyamide 1Mask, Oxygen, Low Concentration, Venturi 1Accessory, Surgical Apparel 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K123034	VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED	2013-05-28
US	K100780	VITAL SUTURES, SUTUREX, CIRUGIA PERUANA	2010-12-14
BR	80149719064	SUTURA DE SEDA AGULHADA	Class II
BR	80149719065	FIO DE SUTURA DE POLIPROPILENO	Class II
BR	80149719067	SUTURA DE NYLON	Class II

UNILENE S.A.C.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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