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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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Ortesis Tibiales — 35 UDI-DI variants, MDR (PRIM, S.A.)

MD Atlas
PRIM, S.A.

Data from EUDAMED, last updated May 23, 2026

Ortesis Tibiales

843404825ORTESISTIBIAXY

35 UDI-DI variants

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

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Manufacturer: PRIM, S.A.

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Device characteristics

No device characteristics flagged

Identity & classification

Basic UDI-DI: 843404825ORTESISTIBIAXY
Device name: Ortesis Tibiales
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Version date: Sep 13, 2022

Manufacturer & authorised representative

Manufacturer

Name: PRIM, S.A.
SRN: ES-MF-000004651
Country: Spain
Email: eudamed1@prim.es
Phone: + 34 91 334 24 00

Variants by status

UDI-DI variants

35 UDI-DI variants

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Applied filters

basicUdiUlid01GCVA6VC2A760PC9X2KJ48QJQ

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

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