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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

A00ES11 — Class I MDR by Furine ApS

MD Atlas
Furine ApS

EUDAMED last updated this device on Jun 11, 2024

A00ES11

57400089A00XX11XZ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Furine ApS
UDI-DI code: 05740008900494
Reference / catalog number: A00ES11

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View device family (Basic UDI)

Manufacturer information

Organization name: Furine ApS
SRN: DK-MF-000001231
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

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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: 05740008900494
Basic UDI-DI: 57400089A00XX11XZ
Reference / catalog number: A00ES11
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: Medical Skin Wipe es una toallita limpiadora que no daña la piel y no contiene alcohol ni perfume. Se utiliza para: Preparar la piel antes de aplicar productos adhesivos, eliminando el exceso de grasa de la piel Facilitar la retirada de los productos adhesivos de la piel una vez que haya finalizado su uso 30 pcs/box
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)05740008900494

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

A108005DEVICES FOR THE REMOVAL OF ADHESIVES FROM THE PERISTOMAL SKIN

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

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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.