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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

B05UK22 — Class I MDR by Furine ApS

MD Atlas
Furine ApS

EUDAMED last updated this device on Jun 10, 2024

B05UK22

57400089B05XX222H

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Furine ApS
UDI-DI code: 05740008900968
Reference / catalog number: B05UK22

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View device family (Basic UDI)

Manufacturer information

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

Related devices

C00157400089C001CVOn the market C20157400089C201D7On the market B05PT2257400089B05XX222HOn the market B05FR2257400089B05XX222HOn the market B05FI2257400089B05XX222HOn the market

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

No critical warnings reported for this device.

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Market distribution

Primary placement in Ireland; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 05740008900968
Basic UDI-DI: 57400089B05XX222H
Reference / catalog number: B05UK22
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 is a non-invasive faecal management system for liquid stools Content: 1 Furine 1 Securin Skin Barrier 1 Furine Collect 2 Medical Skin Wipes 1 Instructions for Use
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)05740008900968

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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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