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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

51030193 — Class I MDR by Orkla Cederroth, SAU

MD Atlas
Orkla Cederroth, SAU

EUDAMED last updated this device on Jun 6, 2024

51030193

8414797TF10PU00S95

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Orkla Cederroth, SAU
UDI-DI code: 08480000796769
Reference / catalog number: 51030193

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Manufacturer information

Organization name: Orkla Cederroth, SAU
SRN: ES-MF-000003606
Manufacturer status: Active

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Critical warnings

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

CW009
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: 08480000796769
Basic UDI-DI: 8414797TF10PU00S95
Reference / catalog number: 51030193
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: Referência da EA: 451181454 EA Deliplus PU Aqua Surti R 12x10 Pensos protetores sortidos com suporte em poliuretano e adesivo acrílico hipoalergénico e compressa central tecido sem tecido com grande poder de absorção.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: Surtidos de diferentes tamaños: 65x19mm, 65x25mm y 65x50mm

EMDN nomenclature code(s)

M04010102POLYURETHANE (OR OTHER MATERIAL) ADHESIVE DRESSINGS, WITH ABSORBENT PAD

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

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.