HomeCanadaPRIMED Medical Products Manufacturing Ltd.

PRIMED Medical Products Manufacturing Ltd.

Canada · Cambridge Ontario
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 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
14listed device types
Class I 10Class II 4Class III 0
plus 56 registration records and 9 510(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
19active device licences
Class II 19
29 including historic records
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
pendingnot queried
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.

United States56 registration records, 9 510(k), 0 PMA, 4 excluded
Brazil0 confirmed, 3 excluded
Canada19 confirmed, 1 excluded
Manufacturer names merged into this page: Gushi priMED Medical Products Manufacturing Co., Ltd. · PRIMED MEDICAL PRODUCTS INC. · PRIMED Laos Medical Products Manufacturing Sole Co., Ltd. · priMED Jiujiang Medical Products Manufacturing Co., Ltd
Same-named companies — This database also contains companies with near-identical names: Primed Medical Products, Inc., Primed Products, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Canada
City
Cambridge Ontario

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.

Business registration

Corporation number
12209403
Registration status
Active
Legal form
Canada Business Corporations Act
Incorporated
2020-07-20
Registered address
200, 2003 - 91 STREET SW, EDMONTON, AB, T6X 0W8

Business registration data from Corporations Canada, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

11989
12008
12009
12016
12022
32024
12025

FDA listed device types

showing 8 of 14
Cap, Surgical 1Dress, Surgical 1Accessory, Surgical Apparel 1Gown, Examination 1Non-Surgical Gown 1Instrument, Manual, Surgical, General Use 1Polymer Patient Examination Glove 1Tray, Surgical 1

Registration details (sample)

MarketIdentifierNameClass / date
USK252964PRIMED Surgical and Procedure Masks2025-11-04
USK242208PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)2024-10-07
USK240286PRIMED Surgical Masks and PRIMED Procedure Masks2024-08-26
CA31412GAUZE, NON ABSORBABLE, X-RAY DETECTABLE (INTERNAL SPONGE)Class II
CA69554PATIENT EXAMINATION GLOVES - LATEXClass II
CA77775INTRAOCULAR INJECTION TRAYClass II

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