HomeTaiwanUnik Surgical Sutures Mfg. Co.

Unik Surgical Sutures Mfg. Co.

Taiwan · New Taipei City · www.unik-suture.com
✓ Record-verifiedregistrations found in 2 marketsEU SRN TW-MF-000037310Unified social credit code 91110105689202007H

This company has registrations in European Union, Singapore — 2 overseas markets. No China NMPA registrations were found.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
0China registrations
as of 2026-09-01
EUEuropean UnionEUDAMED
35UDI-DI device records
Class IIb 35
USUnited StatesFDA openFDA
0listed device types
Class I 0Class II 0Class III 0
plus 0 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
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
2device registrations
CLASS C 2
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.

European Union174 raw hits, 139 excluded, 35 confirmed
United States0 registration records, 0 510(k), 0 PMA, 3 excluded
China0 certificates (Class III 0 / II 0 / I 0), as of 2026-09-01

Regulatory identity

EU manufacturer SRN
TW-MF-000037310
EU authorised representative
Advena Limited
Unified social credit code
91110105689202007H
Exhibition record
CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai)

Company information

Country
Taiwan
City
New Taipei City
Employees
10–50
Annual revenue
RMB 10–30M
Company type
Manufacturer
Website
www.unik-suture.com
Product categories
Integrated Care, Rehabilitation & HomecareConsumables, disposables & infection control

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.

Registration details (sample)

MarketIdentifierNameClass / date
EU04717011552461Class IIb
EU04717011552430Class IIb
EU04717011552416Class IIb
EU04717011552454Class IIb

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