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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

Non Woven Balls — Class I MDR by GS Medical

MD Atlas
GS Medical

EUDAMED last updated this device on Jul 31, 2024

Non Woven Balls

539151646GSMNSNWW2

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: GS Medical
UDI-DI code: 05391516466974
Reference / catalog number: 20013

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Manufacturer information

Organization name: GS Medical
SRN: IE-MF-000010064
Manufacturer status: Active

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: Non Woven Balls
UDI-DI code: 05391516466974
Basic UDI-DI: 539151646GSMNSNWW2
Reference / catalog number: 20013
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: 5
Additional product description: Sterile non-woven gauze balls, 35mm, 5 pack
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 35 MU50

EMDN nomenclature code(s)

M0202010101NON-WOVEN FOLDED GAUZES, WITHOUT X-RAY DETECTABLE THREAD, STERILE

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

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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.