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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

310687 — Class I MDR by Orkla Cederroth, SAU

MD Atlas
Orkla Cederroth, SAU

EUDAMED last updated this device on Jul 6, 2023

310687

8414797TF02PE00S5W

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Orkla Cederroth, SAU
UDI-DI code: 08480024793171
Reference / catalog number: 310687

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Manufacturer information

Organization name: Orkla Cederroth, SAU
SRN: ES-MF-000003606
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.

Critical warnings

2 warnings recorded — scroll inside the panel to see all entries.

CW009
De un solo uso.
CW999
El adhesivo del embalaje contiene látex que puede causar reacciones alérgicas.

Market distribution

Primary placement in Spain; available across 1 country total.

Placed on the market in Spain; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 08480024793171
Basic UDI-DI: 8414797TF02PE00S5W
Reference / catalog number: 310687
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: Pensos cor da pele. Alta proteção para pequenas feridas. Adapta-se à pele deixando-a respirar. Penso de polietileno com adesivo acrílico hipoalergénico e compressa de tecido não tecido revestido por uma camada de polietileno microperforada.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: Surtido de 4 tamaños: 72x19mm; 72x25mm; 56x16mm; 38x10mm.

EMDN nomenclature code(s)

M04010199ADHESIVE DRESSINGS, WITH ABSORBENT PAD - OTHER

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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Software identification