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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

Cotton balls 500g — Class I MDR by Lola Ribar d.o.o. za…

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

EUDAMED last updated this device on Aug 28, 2025

Cotton balls 500g

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: 03858881100237
Reference / catalog number: 1763

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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
Nonsterile product. If the product is not chemically neutral, skin irritation or infection could occur. 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 use after the expiration date.

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: Cotton balls 500g
UDI-DI code: 03858881100237
Basic UDI-DI: 3858890791NESTLR
Reference / catalog number: 1763
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 consist of 500 cotton balls Hydrophilic white chemically neutral cotton fibres shaped into balls and packed. Non-sterile cotton ball intended to help disinfect the injection site. While applying, treat it with the suitable disinfectant. Disinfect the area of application with such treated cotton ball.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: One cotton ball is 1 g ± 5%, sales unit of 500 is 500 g. ± 5%

EMDN nomenclature code(s)

M010103COTTON PAD

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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