Product description:
Sterile, peel pack, rectangular shaped,
Each plaster individually wrapped, Pack of 25 of 50
Elastic fabric, strong adhesion, hypoallergenic adhesive
Waterproof
With of without ventilation holes
Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) of EU Regulations 2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
US FDA 510(K) clearance
CE certificate available for Class IIa and above devices
Manufacturer’s Quality Management System is certified to ISO 13485 : 2016
Classification:
Classified under EU MDR 2017/745 as Class Is device
Safety & product Standards:
Must comply with the following standards (must be compliant as per the latest revisions of standards):
ISO 11607-1 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems.
ISO 10993-1 Biological evaluation of medical devices. Part 1: Evaluation and testing within a risk management process (for the adhesive that is coming in contact with skin)
Sterile, peel pack, rectangular shaped,
Each plaster individually wrapped, Pack of 25 of 50
Elastic fabric, strong adhesion, hypoallergenic adhesive
Waterproof
With of without ventilation holes
Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) of EU Regulations 2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
US FDA 510(K) clearance
CE certificate available for Class IIa and above devices
Manufacturer’s Quality Management System is certified to ISO 13485 : 2016
Classification:
Classified under EU MDR 2017/745 as Class Is device
Safety & product Standards:
Must comply with the following standards (must be compliant as per the latest revisions of standards):
ISO 11607-1 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems.
ISO 10993-1 Biological evaluation of medical devices. Part 1: Evaluation and testing within a risk management process (for the adhesive that is coming in contact with skin)
| Pack Size | Avg. Price |
|---|---|
| Pack of 25 | $0.35 |
| Pack of 1 | $1.73 |
