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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

510003534 — Class I MDR by Orkla Cederroth, SAU

MD Atlas
Orkla Cederroth, SAU

EUDAMED last updated this device on Jun 4, 2024

510003534

8414797TF01PE00S5H

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Orkla Cederroth, SAU
UDI-DI code: 08402001017131
Reference / catalog number: 510003534

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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
Producto de un solo uso
CW999
El adhesivo del sobre de la tira 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: 08402001017131
Basic UDI-DI: 8414797TF01PE00S5H
Reference / catalog number: 510003534
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: Referencia del EA: 510003622 Deliplus Jungle 1x20 Referencia del CS: 510003534 Deliplus Jungle 12x20 Referencia del CS: 510004345 Deliplus Jungles 16x20 Tiras protectoras infantiles surtidas. Composición: soporte de PE (polietileno) resistente al agua con adhesivo acrílico hipoalergénico y compresa central de tejido sin tejer con gran poder de absorción. Tamaño: 8 unidades de 57x16mm, 8 unidades de 72x19mm y 4 unidades de 72x25mm.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 8 unidades de 57x16mm, 8 unidades de 72x19mm y 4 unidades de 72x25mm

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

Batch number
Expiration date
Manufacturing date
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Software identification