Medical device licence · 114408 · Class 2
PROSEAL
Yes: licensed in Canada
Licence status Issued (active); first licensed November 28, 2025. It is in Health Canada’s list of active licences.
- Licence number
- 114408
- Licence holder
- Epic International (Thailand) Co., Ltd.Amphur Pluakdaeng, RY, Thailand
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- November 28, 2025
- Devices covered
- 24
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- PROSEAL BAG SPIKE WITH ADDITIVE PORT
- PROSEAL BAG SPIKE WITH ADDITIVE PORT AND SEAL TAB
- PROSEAL BAG SPIKE WITH NFV ADDITIVE PORT
- PROSEAL CATHETER ADAPTOR
- PROSEAL CHEMOPIN
- PROSEAL CSTD ADMINISTRATION SET WITH ADDITIVE PORT
- PROSEAL CSTD BAG SPIKE WITH ADDITIVE PORT AND NFV OUTLET
- PROSEAL CSTD SECONDARY SET - MALE TO MALE LUER LOCK
- PROSEAL CSTD SECONDARY SET WITH ONE WAY VALVE
- PROSEAL CSTD SYRINGE TRANSFER CONNECTOR
- PROSEAL EXTENSION SETS
- PROSEAL IN LINE PUMP SET
- PROSEAL INJECTION SITE
- PROSEAL INJECTION SITE EXTENDED MALE LUER LOCK
- PROSEAL INJECTION SITE WITH PRIMING CAP
- PROSEAL INJECTOR (SYRINGE ADAPTOR)
- PROSEAL INJECTOR PLUS
- PROSEAL NON-VENTED BAG SPIKE
- PROSEAL PRIMING CAP
- PROSEAL SECONDARY SET
- PROSEAL SECONDARY SET WITH DRIP CHAMBER
- PROSEAL SUBCUT ADAPTOR
- PROSEAL VENTED BAG SPIKE
- PROSEAL VENTED VIAL ADAPTORS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.