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Organization name
UDI-DI code
Reference / catalog number

Abdominal gauze compress 50 x 50… — Class I MDR

MD Atlas
Lola Ribar d.o.o. za proizvodnju saniteta

EUDAMED last updated this device on Aug 29, 2025

Abdominal gauze compress 50 x 50 6 plys.

3858890791NESTLR

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Lola Ribar d.o.o. za proizvodnju saniteta
UDI-DI code: 03858881100541
Reference / catalog number: 1140

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Manufacturer information

Organization name: Lola Ribar d.o.o. za proizvodnju saniteta
SRN: HR-MF-000018260
Manufacturer status: Active

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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.

Critical warnings

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

CW999
Non-sterile product intended for external wounds. Must be sterilised before use. Product is not to be used if the packaging is damaged or the product is visibly unclean. The appropriate packaging for the sterilisation process and the cleanliness of the product during the preparation for sterilisation are to be provided by the healthcare institution. The process of product packaging and its sterilisation are to be carried out using validated methods.Single use only. Do not reuse. Once sterilised, do not resterilise. The edges of the prepared products must be free of loose threads during use. Visible damage to the gauze weave – do not use. Comply with the mandatory hospital procedures of counting medical products before and after use. Do not use after the expiration date. Comply with the mandatory procedures for the disposal of used medical products in accordance with the national laws

Market distribution

Primary placement in Croatia; available across 1 country total.

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

Device identification

Trade name: Abdominal gauze compress 50 x 50 6 plys.
UDI-DI code: 03858881100541
Basic UDI-DI: 3858890791NESTLR
Reference / catalog number: 1140
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: Sales unit consists of 10 pieces.Hydrophilic white gauze, chemically neutral, cut and folded, multi-layered, with stitched edges. Designed to be very efficient in absorbing blood and secretions. Pre-sterilised, the product is intended to be used after surgery for the treatment of external wounds.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 50cm x50cm±1cm, 6sl. /ply

EMDN nomenclature code(s)

M0201030102LAPAROTOMY COTTON GAUZES, WITHOUT X-RAY DETECTABLE THREAD, NON-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

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