Contact:haixiao@sungolytest.com+86 158 2169 5110 (WeChat)+86 132 4819 8029 Members 中文
Home›USA›PRO-TECH DESIGN & MFG., INC.

PRO-TECH DESIGN & MFG., INC.

USA · Santa Fe Springs
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, South Korea — 2 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
75listed device types
Class I 9Class II 44Class III 21unclassified 1
plus 108 registration records and 11 510(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
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
2GMP quality-system certificates
Import 2
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 States108 registration records, 11 510(k), 0 PMA, 81 excluded
Brazil0 confirmed, 23 excluded
Saudi Arabia0 confirmed, 6 excluded
Canada0 confirmed, 9 excluded
Manufacturer names merged into this page: PRO-TECH DESIGN & MFG., INC. · PRO-TECH Design & Mfg, Inc.
Same-named companies — This database also contains companies with near-identical names: Pro Design Intl. AS. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Santa Fe Springs

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

11981
21984
31992 · K923402
21993 · K924752
11994 · K940014
21995 · K940013

FDA listed device types

showing 8 of 75
Knife, Ophthalmic 1Adaptor, Holder, Syringe 1Kit, Surgical Instrument, Disposable 1Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use 1Garment, Storage, Peritoneal Dialysis Catheter 1Hysteroscope Accessories 1Airway, Nasopharyngeal 1Medical Glove, Specialty 1

Registration details (sample)

MarketIdentifierNameClass / date
USK940013BODY POSITION INDICATOR, MODEL BPI11995-05-04
USK940015SNORING MICROPHONE, SM11995-01-11
USK940014PLM SENSOR, MODEL PLM11994-11-10

Similar companies

Abaxis
USA · markets 9
Accorto Regulatory Solutions LLC
USA · markets 0
Accumold LLC
USA · markets 1
AccuVein Inc.
USA · markets 8
Acme Monaco Corporation
USA · markets 4
ACON Laboratories, Inc.
USA · markets 9
Is this your company? Claim the page, add information or report a data error.Claim / report an error →