Contact:haixiao@sungolytest.com+86 158 2169 5110 (WeChat)+86 132 4819 8029 Members 中文
Home›USA›Pressure Products Medical Device Manufacturing, LLC

Pressure Products Medical Device Manufacturing, LLC

USA · Morton
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Canada, Singapore, 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
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
5listed device types
Class I 2Class II 3Class III 0
plus 11 registration records and 10 510(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
3 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
1device registrations
CLASS D 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
Class III 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 States11 registration records, 10 510(k), 0 PMA, 4 excluded
Brazil0 confirmed, 2 excluded
Saudi Arabia0 confirmed, 2 excluded
Manufacturer names merged into this page: PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC
Same-named companies — This database also contains companies with near-identical names: Pressure Products, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Morton

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

11998
22017
32018
12021
12022
12024
12026

FDA listed device types

Orthosis, Limb Brace 1Bandage, Elastic 1Trocar 1Catheter, Septostomy 1Introducer, Catheter 1

Registration details (sample)

MarketIdentifierNameClass / date
USK253799SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)2026-03-13
USK241042SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)2024-05-17
USK221707SafeSept® Transseptal Guidewire (SS-140)2022-09-14

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 →