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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

Lubricen® Knee Patch — Class I MDR by Wellfully Limited

MD Atlas
Wellfully Limited

EUDAMED last updated this device on Mar 17, 2022

Lubricen® Knee Patch

539154221SW0228Y

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Wellfully Limited
UDI-DI code: 05391542210022
Reference / catalog number: NA

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Manufacturer information

Organization name: Wellfully Limited
SRN: IE-MF-000021118
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW011
Use on self. Not suitable for children or pregnant women. Disocntinue of irritation occurs. Do not freeze. Store at below 30C. May contain ingredients derived from shelfish. Keep away from children. Use on those who does not have electronic device insid their bodies.

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: Lubricen® Knee Patch
UDI-DI code: 05391542210022
Basic UDI-DI: 539154221SW0228Y
Reference / catalog number: NA
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: 8
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

M040799SPECIAL PADS - 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

Related devices

Lubricen® Knee Patch539154221SW01593On 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.