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

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Planmeca ProMax — 4 UDI-DI variants, MDR (Planmeca Oy)

MD Atlas
Planmeca Oy

Data from EUDAMED, last updated May 23, 2026

Planmeca ProMax

6430035420165S

4 UDI-DI variants

MDR [Regulation (EU) 2017/745 on medical devices]Class IIb

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIb
Manufacturer: Planmeca Oy

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Device characteristics

Active device

Legacy certificates

Certificate number: FI23/00000059
Type: refdata.certificate-mdr-type.quality-management-system
Notified body: SGS FIMKO OY (0598)
Validity: Sep 17, 2025 → Jun 26, 2030

Identity & classification

Basic UDI-DI: 6430035420165S
Device name: Planmeca ProMax
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIb
Version date: Jul 3, 2024

Manufacturer & authorised representative

Manufacturer

Name: Planmeca Oy
SRN: FI-MF-000006499
Country: Finland
Email: niina.vuorikallas@planmeca.com

Variants by status

UDI-DI variants

4 UDI-DI variants

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Applied filters

basicUdiUlid01J1W85NF944HBV833PS2ZN9ST

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

3003858106430035420933
3005678806430035421022
3000310706430035420452
3000310806430035420445