Planmed Verity Digital Mammography System

Regulatory status

as of registry sync 7 Nov 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	NumberFI23/0000004	Date5 Aug 2025Issued	StatusActive expires 4 Aug 2029
European Union	CE/MDR EUDAMED	Number6430035430015L Basic UDI-DI 06430035430109UDI-DI	Date17 May 2023Registered	StatusActive
United States	FDA 510(k) 510(k)	NumberK213278	Date28 Apr 2022Issued	StatusActive
United States	FDA 510(k) 510(k)	NumberK180918	Date30 Nov 2018Issued	StatusActive
United States	FDA 510(k) 510(k)	NumberK143435	Date14 May 2015Issued	StatusActive
United States	FDA 510(k) 510(k)	NumberK121418	Date1 Feb 2013Issued	StatusActive

Official records

EUDAMED public site Basic UDI-DI 6430035430015L — open Devices and search for it
FDA 510(k) database 510(k) number K213278
FDA 510(k) database 510(k) number K180918
FDA 510(k) database 510(k) number K143435
FDA 510(k) database 510(k) number K121418

Across registries

2 registries list this device

EUDAMED Basic UDI-DI 6430035430015L registered 17 May 2023 Active· +1 more in the status table
FDA 510(k) K213278 decided 28 Apr 2022 Active· +3 more in the status table

Certificates

1 certificate · EUDAMED

FI23/0000004 Active Reissued

Quality management system EU MDR

Certifier

SGS FIMKO OY 0598

Issued
5 Aug 2025

Expires
4 Aug 2029

Timeline

7 dated events

1 Feb 2013 Cleared FDA 510(k) K121418
14 May 2015 Cleared FDA 510(k) K143435
30 Nov 2018 Cleared FDA 510(k) K180918
28 Apr 2022 Cleared FDA 510(k) K213278
17 May 2023 Registered EUDAMED 6430035430015L
5 Aug 2025 Certificate issued EUDAMED FI23/0000004
4 Aug 2029 Certificate expires EUDAMED FI23/0000004

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDR Active
United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Model / reference: 30010465

Primary DI / UDI-DI: 06430035430109
Basic UDI-DI: 6430035430015L
EMDN code: Z11039099 Various radiodiagnostic and interventional instruments – other

Device class: Class IIb
EU registration type: Standard device
EU market of registration: Finland

Manufacturer details

EUDAMED SRN: FI-MF-000006837

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Planmed Verity is a mammography system (Nomenclature Code: Z11039099), designed for digital breast imaging to produce high-resolution X-ray images of breast tissue. It operates as a Class IIb medical device, adhering to strict regulatory standards for diagnostic imaging equipment.

This device is supplied as a non-sterile, non-reusable system intended for use in radiology departments or imaging centers. It is not implantable or intended for administering medicine, and its UDI (Basic UDI: 6430035430015L) ensures traceability. Authorized under FDA 510K and MDR compliance, it requires proper calibration and maintenance in accordance with manufacturer guidelines.

Category: Electromagnetic surgical navigation device tracking system