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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

Z3535L — Class I MDR by ALGRAN MANUFACTURA…

MD Atlas
ALGRAN MANUFACTURA SANITARIA, S.L.

EUDAMED last updated this device on May 15, 2026

Z3535L

8437013MCTALX7

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ALGRAN MANUFACTURA SANITARIA, S.L.
UDI-DI code: 08437013599429
Reference / catalog number: Z3535L

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Manufacturer information

Organization name: ALGRAN MANUFACTURA SANITARIA, S.L.
SRN: ES-MF-000042506
Manufacturer status: Active

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement	May 11, 2013	Dec 30, 2050

Device identification

Trade name: not provided
UDI-DI code: 08437013599429
Basic UDI-DI: 8437013MCTALX7
Reference / catalog number: Z3535L
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: FINALIDAD: Limitar y controlar el movimiento de las extremidades superiores en pacientes que así lo requieran. INSTRUCCIONES DE USO • Usuario previsto de este producto será un profesional sanitario. • Coloque el inmovilizador alrededor de la muñeca con la anilla hacia el exterior. • Ajuste y fije con el cierre de velcro. • Rodee la muñeca con la cinta de sujeción y átela a la anilla con un nudo doble para evitar estrangulamientos de la muñeca del paciente. • Anudar el extremo de la cinta al bastidor de la cama o silla.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y060613WRIST-HAND-FINGERS 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

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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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.