HomeJapanGUNZE LIMITED

GUNZE LIMITED

Japan · Ayabe Ky?To
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Taiwan, Singapore, South Korea, Hong Kong, Israel, Russia — 8 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
2listed device types
Class I 0Class II 1Class III 0unclassified 1
plus 4 registration records and 5 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
1 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
3valid device licences
Class I 1Class II 2
SGSingaporeHSA SMDR
2device registrations
CLASS D 2
KRSouth KoreaMFDS GMP
3GMP quality-system certificates
Import 3
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
1valid listings
Class IV 1
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
1active registrations
Class 3 1
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 States4 registration records, 5 510(k), 0 PMA, 1 excluded
Manufacturer names merged into this page: GUNZE LIMITED

Company information

Country
Japan
City
Ayabe Ky?To

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Corporate Number
7130001041734
Registration status
Active
Registered capital
JPY 26,071,000,000

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

FDA 510(k) clearances by year

12013 · K130997
12020 · K191992
32022 · K221487

FDA listed device types

Mesh, Surgical, Absorbable, Staple Line Reinforcement 1Wound Dressing With Animal-Derived Material(S) 1

Registration details (sample)

MarketIdentifierNameClass / date
USK221487NEOVEIL Staple Line Reinforcement2022-08-26
USK213498PELNAC Meshed Bilayer Wound Matrix2022-07-14
USK213573PELNAC Wound Matrix2022-02-09

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