HomeTaiwanADVANCED MEDICAL DESIGN CO., LTD.

ADVANCED MEDICAL DESIGN CO., LTD.

Taiwan · New Taipei City
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, South Korea, Australia, Hong Kong, Israel — 5 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
pendingnot queried
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
8listed device types
Class I 5Class II 3Class III 0
plus 8 registration records and 5 510(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
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
2GMP quality-system certificates
Import 2
AUAustraliaTGA ARTG
23active ARTG entries
Class I 9IIa 10IIb 2Class Is (sterile) 2
HKHong KongMDACS
4valid listings
Class II 1Class III 3
ILIsraelAMAR
1registrations
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 States8 registration records, 5 510(k), 0 PMA, 155 excluded
Brazil0 confirmed, 8 excluded
Saudi Arabia0 confirmed, 1 excluded
Canada0 confirmed, 11 excluded
Manufacturer names merged into this page: ADVANCED MEDICAL DESIGN CO., LTD.

Company information

Country
Taiwan
City
New Taipei City

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.

FDA 510(k) clearances by year

12002 · K022712
22012 · K122497
12019 · K181887
12021 · K210248

FDA listed device types

Tubing/Tubing With Filter, Insufflation, Laparoscopic 1Instrument, Ligature Passing And Knot Tying 1Accessories, Cleaning Brushes, For Endoscope 1Instrument, Manual, Surgical, General Use 1Laparoscopic Accessories, Gynecologic 1Anti Fog Solution And Accessories, Endoscopy 1Laparoscope, General & Plastic Surgery 1Insufflator, Laparoscopic 1

Registration details (sample)

MarketIdentifierNameClass / date
USK210248Lab Bag with Fabric Pouch2021-07-30
USK181887AMD Anti-Fog Solution2019-01-22
USK122497ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 14MM ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 16MM2012-10-15

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