What is the stated classification for OSH 250 ml?
The site identifies OSH 250 ml as a class IIb medical device and reports CE marking 2764 in the MDR transitional regime stated in the website documentation.
OSH OSH 250 ml
OSH 250 ml · REF OSH-200
OSH Vacuum Citrate Bottle | MDR Compliance and Documentation
MDR compliance, CE marking and regulatory documentation for the OSH-200 250 ml vacuum citrate bottle medical device in Europe.
At a glance
The regulatory documentation identifies the device, its stated marking and Devamed S.r.l. as importer and exclusive distributor in Italy. For every use or verification, the label, IFU and current official documentation prevail.
STATED TECHNICAL DATA
Stated regulatory references
Documentary summary to be verified against current official documentation.
| Classification | Class IIb medical device |
|---|---|
| Marking | CE 2764 |
| Stated regime | Directive 93/42/EEC · MDR transitional regime until 31 December 2027 |
| Devamed role | Importer and exclusive distributor in Italy pursuant to MDR Articles 13 and 14 |
Informational technical summary; the label, IFU and official documentation prevail.
Information for healthcare professionals
Technical information publicly available for documentary transparency, to be read together with the official documentation.
Technical questions
What is Devamed's role?
Devamed is identified as the exclusive distributor in Italy and as importer and distributor pursuant to MDR Articles 13 and 14.
How can the IFU and declaration of conformity be requested?
The instructions for use and EU declaration of conformity can be requested directly from Devamed using the contact paths on the page.
Who are the technical information pages intended for?
The website information is reserved for physicians and qualified healthcare professionals and does not replace clinical assessment or the official IFU.