Documentation
Authority requirements, product specifications and documentation
STANDARD INFORMATION
Our products include information such as:
- number
- Description
- Cost
- Number per packages
- EAN code per device
- EAN code per packages</ li>
- Datasheet
- User Guide
- Delivery time
- Weight per. device
- Dimensions of unit H x W x L in mm
- Code Duty
- origin
- Regulatory Compliance
- High resolution image capability
BASIC UDI
In May 2020, a Medical Devices Regulation will come into force, with many stricter requirements for medical device manufacturers, hospitals and other healthcare providers.
The regulation requires products to be UDI- tag , i.e. with a unique barcode containing the product’s GTIN and information such as batch number, expiry date and more. Master data on the products in the European data pool, EUDAMED, must also be recorded.
The regulation should support that you have a good overview of products with the same characteristics as can be used in any recall situation. For example, if there is a problem with a catheter in size 6, there is a risk of a similar one for other sizes.
DOCUMENTATION
Safecare Nordic guarantees that the products we sell comply with applicable legislation and documentation requirements.
We are constantly to new rules in the field and of course have data sheets, CE Certificates and other necessary documentation on all our products.
Code of Conduct
We also have a Code of Conduct document , which supports our ambition to show responsibility towards general working conditions, child labor, ethical and environmental issues, etc.
Documentation and Code of Conduct on request.
EXAMPLE OF DATA SHEET
Click to see an example of a technical datasheet for the Eye Rinse product.
Example of technical data sheet
Other links
Brancheforening for Personligt Arbejdsmiljø
www.bpa-esf.dk
Dansk Standard
www.ds.dk
European Safety Federation (ESF)
www.european-safety-federation.org
ICAN A/S
www.ican.as