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Mast Biosurgery USA, Inc.

USA · San Diego

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Taiwan, South Korea — 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

pendingnot queried

USUnited StatesFDA openFDA

3listed device types

Class I 0Class II 2Class III 1

plus 5 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

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

1 including historic records

TWTaiwanTFDA

3valid device licences

Class III 3

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

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 States5 registration records, 6 510(k), 0 PMA, 4 excluded

Brazil0 confirmed, 1 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: MAST BIOSURGERY USA INC.

FDA 510(k) clearances by year

12005 · K050332

12006 · K061473

12007 · K063648

12008 · K072190

12010 · K090637

12021 · K200918

FDA listed device types

Barrier, Absorbable, Adhesion 1Pericardial Patch To Facilitate Revision Surgeries 1Mesh, Surgical, Polymeric 1

Market	Identifier	Name	Class / date
US	K200918	SurgiWrap FROST	2021-01-07
US	K090637	CARDIO-WRAP	2010-01-07
US	K072190	ORTHO-WRAP BIORESORBABLE SHEET	2008-01-16

Mast Biosurgery USA, Inc.

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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