Blog Pricing Sign in

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Blog Partners Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

MD Atlas
Documents

Planmed Oy

Certificate FI23/0000004

Rev. Issue 3Supplemented

Valid until: Jan 23, 2027

Overview

Certificate number: FI23/0000004
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 3
Certificate ID: 0598FI23/0000004Issue 3

Validity

Issued: Feb 13, 2024
Valid from: Feb 13, 2024
Valid until: Jan 23, 2027

Manufacturer

Manufacturer: Planmed Oy
Manufacturer SRN: FI-MF-000006837
Manufacturer country: Finland

Notified body

Notified body: SGS FIMKO OY
Notified body SRN: 0598
Notified body country: Finland

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: No
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: No
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: Yes
Intended medical purpose: No
SPP applicable: No
Conditions applicable: Yes
MOS outside EUDAMED: —
QMS/MOS type: Class IIb only

History

Status changes

Supplemented

Supersedes

FI23/0000004Quality management systemSupplementedDec 4, 2023 → Jan 23, 2027

Scope coverage

Class IIb4

4 scopes

Z11030202: Diagnostic X-ray equipment and accessories
Class IIb
Z110306: Computed tomographs (ct)
Class IIb
Planmed Verity
Class IIb
Model: Planmed Clarity; Variants: Planmed Clarity S, Planmed Clarity 2D, Planmed Clarity 3D
Class IIb

Documents

LanguagesEN