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Organization name
UDI-DI code
Reference / catalog number

Sterile Compresses 5x5 12ply.. á… — Class I MDD

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

EUDAMED last updated this device on Aug 19, 2025

Sterile Compresses 5x5 12ply.. á 1pcs

B-03858881103214

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Lola Ribar d.o.o. za proizvodnju saniteta
UDI-DI code: 03858881103214
Reference / catalog number: 1183

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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
Product is not to be used if the packaging is damaged or the product is visibly unclean. Single use only. Do not reuse. 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. Do not use after the expiration date. Comply with the mandatory hospital procedures of counting medical products before and after use. Comply with the mandatory procedures for the disposal of used medical products in accordance with the national laws Monitor the health condition and change the dressing as necessary.

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: Sterile Compresses 5x5 12ply.. á 1pcs
UDI-DI code: 03858881103214
Basic UDI-DI: B-03858881103214
Reference / catalog number: 1183
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Sales unit consists of 1 piece in pouch. High-quality cotton fabric sterilised and individually packed. The edges of the cloth are folded inwards so that threads cannot be detached. The product is sterile until individual package is opened or damaged. Used for treating a wide range of external wounds due to its high absorbency, mainly: for cleaning wounds, as a wound dressing, for absorbing secretions, as a patch for absorbing medical ointment.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: Složena/folded 5cmx5cm ±0,5 cm

EMDN nomenclature code(s)

M0201020101COTTON GAUZES, FOLDED, 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

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Expiration date
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