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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

B05PT22 — Class I MDR by Furine ApS

MD Atlas
Furine ApS

EUDAMED last updated this device on Jun 10, 2024

B05PT22

57400089B05XX222H

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Furine ApS
UDI-DI code: 05740008901569
Reference / catalog number: B05PT22

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View device family (Basic UDI)

Manufacturer information

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

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C00157400089C001CVOn the market C20157400089C201D7On the market B05FR2257400089B05XX222HOn the market B05FI2257400089B05XX222HOn the market B05EL2257400089B05XX222HOn the market

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Portugal; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 05740008901569
Basic UDI-DI: 57400089B05XX222H
Reference / catalog number: B05PT22
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: Furine é um sistema de gestão fecal não invasivo para fezes líquidas Conteúdo: 1 Furine 1 Securin Skin Barrier 1 Furine Collect 2 Medical Skin Wipes 1 Guia de aplicação
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)05740008901569

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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.

A060399FLUID COLLECTION BAGS AND SYSTEMS - 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

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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.