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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

URGO KTwo — Class I MDR by LABORATOIRES URGO

MD Atlas
LABORATOIRES URGO

EUDAMED last updated this device on Mar 9, 2023

URGO KTwo

354689UM00314T

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: LABORATOIRES URGO
UDI-DI code: 03546890029686
Reference / catalog number: 552897

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Manufacturer information

Organization name: LABORATOIRES URGO
SRN: FR-MF-000002559
Manufacturer status: Active

Related devices

Bande adhésive élastique354689UM00204NOn the market 605881354689UM008058On the market 605880354689UM008058On the market 605847354689UM00685JOn the market 605968354689UM00785MOn 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

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

CW011
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in XI; available across 2 countries total.

Country	On market since	Until
XIPrimary placement		Still on market
Ireland		Still on market

Device identification

Trade name: URGO KTwo
UDI-DI code: 03546890029686
Basic UDI-DI: 354689UM00314T
Reference / catalog number: 552897
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 12cm
25-32cm

EMDN nomenclature code(s)

M03040199ELASTIC COMPRESSION BANDAGES - 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
Serial number
Software identification