Scarlet NB B.V.

🇳🇱 Netherlands · Amsterdam Active

www.scarlet.cc

Designations

MDR Medical devices · Regulation (EU) 2017/745 Active

Conformity assessment annexesAnnex IX(I), Annex IX(II)

Designated since2023-11-25

MDA 0315Software

Full scope text from the register

Annexes

Annex IX(I), Annex IX(II)

Procedures

Conformity assessment based on a quality management system, Conformity assessment based on assessment of technical documentation

Products

3. Active non-implantable therapeutic devices and general active non-implantable devices
MDA 0315 Software
A. Active devices
I. CODES REFLECTING THE DESIGN AND INTENDED PURPOSE OF THE DEVICE

MDR Medical devices · Regulation (EU) 2017/745 Active

Conformity assessment annexesAnnex IX(I), Annex IX(II)

Designated since2023-11-25

MDA 0315Software

Full scope text from the register

Annexes

Annex IX(I), Annex IX(II)

Procedures

Conformity assessment based on a quality management system, Conformity assessment based on assessment of technical documentation

Products

3. Active non-implantable therapeutic devices and general active non-implantable devices
MDA 0315 Software
A. Active devices
I. CODES REFLECTING THE DESIGN AND INTENDED PURPOSE OF THE DEVICE

Source: EU Single Market Compliance Space (SMCS), retrieved 2026-06-23.
https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/free-search?text=3022

This page is an informational mirror of the official register. It is not affiliated with the European Commission. Always verify the current designation and scope against the official SMCS record before relying on it.