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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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Organization name
UDI-DI code
Reference / catalog number

TIBAX — Class I MDR by PRIM, S.A.

MD Atlas
PRIM, S.A.

EUDAMED last updated this device on May 13, 2026

TIBAX

843404825ORTESISTIBIAXY

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: PRIM, S.A.
UDI-DI code: 08426680668835
Reference / catalog number: TIBAX

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Manufacturer information

Organization name: PRIM, S.A.
SRN: ES-MF-000004651
Manufacturer status: Active

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

Market distribution

Primary placement in Spain; available across 2 countries total.

Country	On market since	Until
SpainPrimary placement		Still on market
Portugal		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08426680668835
Basic UDI-DI: 843404825ORTESISTIBIAXY
Reference / catalog number: TIBAX
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Lower Limb Correction Orthosis TIBAX. Allows a quick and exact adjustment of the correcting rotation of both feet. This rotational adjustment can be read on a graduated scale. • Allows the shoe adaptation to each platform or direct placing of BEBAX orthosis, being able to act simultaneously in the front foot malformations. • Supplied with two bars and with the necessary elements to adapt to conventional bootees or to BEBAX orthosis, which are sold separately.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y061218HIP-KNEE-ANKLE-FOOT ORTHOSES

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

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