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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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Export results

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

AIRTEX One Size Calf Support08434048418480
AIRTEX OS Neoprene Calf Support08434048030231
AQTIVO Sport Neoprene Calf Support08434048105649
AQTIVO Sport Neoprene Calf Support08434048105632
AQTIVO Sport Neoprene Calf Support08434048105656
H1 LR08426680629218
C12 L08426680668576
C11 R08426680668545
C11 L08426680668552
C12 R08426680668569
C22 R08426680668521
C22 L08426680668538
C21 R08426680668507
C21 L08426680668514
NEOPRAIR OS Neoprene Calf Support08434048106226
Sarmiento cast brace08426680629249
Sarmiento Cast brace08426680629133
Sarmiento Cast Brace08426680629256
Sarmiento Cast Brace08426680629096
Sarmiento Cast Brace08426680629126
Sarmiento Cast Brace08426680629232
Sarmiento Cast Brace08426680629225
Sarmiento Cast Brace08426680629102
Sarmiento Cast Brace08426680629140
Sarmiento Cast Brace08426680629171

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