Accreditation
Pyng Medical continues to maintain FDA registration, Canadian licensing, ISO 9001:2000 and ISO 13485:2003 certification in order to ensure Pyng Medical meets customer satisfaction and all current US and international medical device regulations and standards.
FAST1® Intraosseous Infusion System
Our accreditation allows us to sell the FAST1® Intraosseous Infusion System in the US, Canada, Europe and internationally in countries such as Australia and South Africa, as well as throughout Asia.
- CE Marking
- FDA 510k Clearances
- Health Canada License
- ISO 9001:2000 Certificate
- ISO 13485:2003 CMDCAS Certificate
- ISO 13485:2003 UKAS Certificate
T-POD® Pelvic Stabilizer
As a class 1 device, formal accreditation is not necessary. T-POD® can be sold in Canada, US, EU, and internationally.
MAT® Tourniquet
As a class 1 device, formal accreditation is not necessary. MAT® can be sold in Canada, US, EU, and internationally.
CRIC™ Cricothyrotomy System
CRIC™ is currently not for sale, pending FDA clearance.
