HomeTaiwanNew Deantronics Taiwan , Ltd.

New Deantronics Taiwan , Ltd.

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

This company has registrations in United States, Canada, South Korea, Australia, 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
13listed device types
Class I 3Class II 9Class III 1
plus 61 registration records and 21 510(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
4active device licences
Class II 4
11 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
5GMP quality-system certificates
Import 5
AUAustraliaTGA ARTG
1active ARTG entries
IIb 1
HKHong KongMDACS
pendingnot queried
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 States61 registration records, 21 510(k), 0 PMA
Canada4 confirmed, 0 excluded
Manufacturer names merged into this page: NEW DEANTRONICS TAIWAN LTD. · New Deantronics Taiwan Ltd. - Chiayi · NEW DEANTRONICS, LTD.
Same-named companies — This database also contains companies with near-identical names: NEW DEANTRONICS, LTD.. Company name alone cannot separate their registrations, so the figures below may include either.

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

81998
12015
12016
12017
12018
42019
32020
12025
12026

FDA listed device types

showing 8 of 13
Orthopedic Manual Surgical Instrument 1Instrument, Manual, Surgical, General Use 1Air-Handling Apparatus Accessory 1Electrosurgical, Cutting & Coagulation & Accessories 1Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component 1Arthroscope 1Cable, Transducer And Electrode, Patient, (Including Connector) 1Endoscope, Neurological 1

Registration details (sample)

MarketIdentifierNameClass / date
USK251492Irrigation Tubing Bipolar Cord Set2026-06-29
USK251899E Blator2025-10-01
USK202962Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D1, Smoke Evacuation Button Switch Pencil, Non-Ext., 15ft, D1, Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D2, Smoke Evacuation Button Switch Pencil, Non-Ext., 15ft, D2, Telescopic Smoke Evacuation Button Switch Pencil, 10ft, Telescopic Smoke Evacuation Button Switch Pencil, 15ft, Telescopic Smoke Evacuation Button Switch Pencil, 15ft, Telescopic Smoke Evacuation Button Switch Pencil, Lock, 15ft2020-11-20
CA103294ARGON ELECTRODESClass II
CA104801MONOPOLAR CORDClass II
CA104802ARGON HANDSETClass II

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