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Organization name
UDI-DI code
Reference / catalog number

LOLA CARE - CALICO BANDAGE WITH… — Class I MDR

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

EUDAMED last updated this device on Aug 20, 2025

LOLA CARE - CALICO BANDAGE WITH WOVEN EDGE 4cmx 5m

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: 03858881107250
Reference / catalog number: 1401

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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. Not to be directly applied onto the wound. If there is skin damage in the area where the calico bandage is applied, it is necessary to first dress the wound with primary sterile materials then applied bandage as secondary protection. Product is not to be used if the packaging is damaged or the product is visibly unclean. Single use only. Do not reuse. Once sterilised, do not resterilise. Do not use after the expiration date. Improper use when protecting the wound from the pressure of bandages, as well as protection against potential damage caused by external force can cause blisters, skinfolds, itching and redness of the skin. 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: LOLA CARE - CALICO BANDAGE WITH WOVEN EDGE 4cmx 5m
UDI-DI code: 03858881107250
Basic UDI-DI: 3858890791NESTLR
Reference / catalog number: 1401
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 1 piece. Narrowly woven strip made from row cotton. Intended to help immobilise and fix various body parts. Used as aid in fixing bandages onto various body parts, for putting body parts at rest, and for compression
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 4 cm x 5 m; ± 0,5 cm širina/widith, dužina/lenght± 10 cm

EMDN nomenclature code(s)

M0299GAUZES - 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

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