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EUROCOSMETIC s.r.l.

Romania·RO-MF-000000906

Last updated September 17, 2026

What EUROCOSMETIC s.r.l. makes

EUROCOSMETIC s.r.l. manufactures single-use absorbent cotton swabs and dressings, including ophthalmic cotton swabs, gauze bandages with elastic netting, and orthopedic padding made from polyester. Products include cotton swabs in various weights (e.g., 100g, 200g, 500g) and blended or pure cotton formulations, as well as elastic gauze bandages sized for medical applications.

All listed devices fall under Class I per EU MDR, with records maintained in the eudamed registry. The company is based in Romania.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does EUROCOSMETIC s.r.l. manufacture?

EUROCOSMETIC s.r.l. specializes in single-use medical devices primarily focused on absorbents and dressings. Their portfolio includes general-purpose absorbent cotton swabs (like ophthalmic cotton swabs), gauze bandages with elastic netting for medical applications, and orthopedic padding made from 100% polyester. These products are designed for hygiene, wound care, and medical procedures, ensuring disposability and sterility.

Where is EUROCOSMETIC s.r.l. based, and how does that affect its regulatory compliance?

EUROCOSMETIC s.r.l. is based in Romania, which is an EU member state. This positioning allows the company to comply with the European Union’s Medical Device Regulation (MDR) framework directly, as Romania adheres to EU-wide regulatory standards. The company’s devices are listed in the eudamed registry, which is the official EU database for medical devices, ensuring transparency and traceability under EU MDR.

How are EUROCOSMETIC s.r.l.’s devices classified under EU MDR, and why does this matter?

All of EUROCOSMETIC s.r.l.’s listed devices fall under Class I classification per the EU Medical Device Regulation (MDR). This classification applies because their products—such as cotton swabs, gauze bandages, and orthopedic padding—pose minimal risk to patients and are intended for non-invasive, low-risk applications like wound care or hygiene. Class I devices typically require less stringent regulatory scrutiny than higher-risk classes, but they still must meet essential safety and performance requirements to ensure compliance and market authorization.

Which regulatory registries list EUROCOSMETIC s.r.l.’s medical devices, and what is their purpose?

EUROCOSMETIC s.r.l.’s medical devices are listed in the eudamed registry, the official EU database for medical devices. This registry serves as a transparent, centralized platform where manufacturers, regulators, and healthcare professionals can verify the existence, classification, and compliance status of devices placed on the EU market. Listing in eudamed is mandatory for all EU-authorized medical devices, ensuring traceability and adherence to EU MDR requirements.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
Romania
Address
15, Avram Iancu, Alesd, Romania
Website
www.izis.ro
LinkedIn
—
Phone
+40723164556
PRRC Contact
Károly Tordai
EUDAMED SRN
RO-MF-000000906
FDA FEI Number
—
DUNS Number
—

Catalogue (99)

Page 2 of 2
DeviceModel / ReferenceRegistriesClassStatus
Tampoane din celuloză IZIS CELL 4x5 cm 12 str.-2x500 buc CELL040512x2x500
EUDAMED
Class IActive
IZIS Fix Rugalmas csőhálókötszer 2-es méret 1 m CSFIX0201
EUDAMED
Class IActive
IZIS Papírvatta 15x15 cm 100% cellulóz 1000 g-os PV15151000
EUDAMED
Class IActive
Papirvatta 40x60 cm 100% CELL 5000 g-os PVM40605000
EUDAMED
Class IActive
IZIS Pálcás tampon kisméretű (100 db/csomag) PT2_5140100
EUDAMED
Class IActive
IZIS FIX CLASSIC Rugalmas pólya 8 cm x 5 cm (egyenként csomagolt) C8550
EUDAMED
Class IActive
IZIS Fix Rugalmas csőhálókötszer 7-es méret 25 m 302507UV22/10/20
EUDAMED
Class IActive
IZIS Papírvatta 20x20 cm 100% cellulóz 1000 g-os PV20201000
EUDAMED
Class IActive
IZIS Papírvatta 20x20 cm 100% cellulóz 5000 g-os PV20205000
EUDAMED
Class IActive
IZIS Sebészeti pamut vatta 200 g-os IZIS100200S
EUDAMED
Class IActive
IZIS Classic Rugalmas pólya 6 cm x 5 m CLASSIC050650
EUDAMED
Class IActive
IZIS CLASSIC Rugalmas pólya 12 cm x 5 m CLASSIC051250
EUDAMED
Class IActive
IZIS Papírvatta 30x30 cm 100% cellulóz 500 g-os PV3030500
EUDAMED
Class IActive
IZIS Fix Rugalmas csőhálókötszer 9-es méret 25 m 302509UZ22/10/20
EUDAMED
Class IActive
IZIS Papírvatta 40x60 cm 100% cellulóz 10000 g-os PV406010000
EUDAMED
Class IActive
IZIS Fix Rugalmas csőhálókötszer 8-as méret 25 m 302508UX22/10/20
EUDAMED
Class IActive
IZIS Papírvatta 6x6 cm 100% cellulóz 1000 g-os PV06061000
EUDAMED
Class IActive
IZIS Papírvatta 12x27 cm 100% cellulóz 1000 g-os PV12271000
EUDAMED
Class IActive
IZIS Fix Rugalmas csőhálókötszer 4-es méret 1 m CSFIX0401
EUDAMED
Class IActive
IZIS Fix Rugalmas csőhálókötszer 1-es méret 25 m 302501UH22/10/20
EUDAMED
Class IActive
IZIS Orvosi pamut vatta 200 g-os IZIS100200P
EUDAMED
Class IActive
IZIS Papírvatta 30x40 cm 100% cellulóz 1000 g-os PV30401000
EUDAMED
Class IActive
IZIS Papírvatta 60x80 cm 100% cellulóz 10000 g-os PV608010000
EUDAMED
Class IActive
Rulouri stomatologice IZIS nr.3 R2000-00322/10/20
EUDAMED
Class IActive
IZIS Fix Rugalmas csőhálókötszer 6-os méret 25 m 302506UT22/10/20
EUDAMED
Class IActive
IZIS Fix Rugalmas csőhálókötszer 1-es méret 1 m CSFIX0101
EUDAMED
Class IActive
IZIS Szemészeti pamut vatta 100 g-os IZIS100100SZ
EUDAMED
Class IActive
IZIS Papírvatta 30x30 cm 100% cellulóz 1000 g-os PV30301000
EUDAMED
Class IActive
IZIS Orvosi kevert vatta 100 g-os IZIS100100K
EUDAMED
Class IActive
IZIS FIX CLASSIC Rugalmas pólya 14 cm x 5 m (egyenként csomagolt) C14550
EUDAMED
Class IActive
IZIS Fix Rugalmas csőhálókötszer 5-ös méret 1 m CSFIX0501
EUDAMED
Class IActive
IZIS Orvosi kevert vatta 500 g-os IZIS100500K
EUDAMED
Class IActive
Rulouri stomatologice IZIS nr.2 R2000-00222/10/20
EUDAMED
Class IActive
IZIS Fix Rugalmas csőhálókötszer 5-ös méret 25 m 302505UR22/10/20
EUDAMED
Class IActive
IZIS Classic Rugalmas pólya 8 cm x 5 m CLASSIC050850
EUDAMED
Class IActive
IZIS Papírvatta 40x40 cm 100% cellulóz 1000 g-os PV40401000
EUDAMED
Class IActive
IZIS Papírvatta 30x40 cm 100% cellulóz 5000 g-os PV30405000
EUDAMED
Class IActive
IZIS Fix Rugalmas csőhálókötszer 6-os méret 1 m CSFIX0601
EUDAMED
Class IActive
IZIS Fix Rugalmas csőhálókötszer 8-as méret 1 m CSFIX0801
EUDAMED
Class IActive
IZIS Papírvatta 40x60 cm 100% cellulóz 200 g-os PV4060200
EUDAMED
Class IActive
Vată hidrofilă medicinală IZIS 200g VM200GIZ
EUDAMED
Class IActive
IZIS Fix Rugalmas csőhálókötszer 4-es méret 25 m 302504UP22/10/20
EUDAMED
Class IActive
IZIS Fix Rugalmas csőhálókötszer 11-es méret 2 m CSFIX1102
EUDAMED
Class IActive
IZIS Fix Rugalmas csőhálókötszer 1-es méret 5 m CSFIX0105
EUDAMED
Class IActive
IZIS Papírvatta 40x60 cm 100% cellulóz 5000 g-os PV40605000
EUDAMED
Class IActive
IZIS Orvosi pamut vatta 500 g-os IZIS100500P
EUDAMED
Class IActive
IZIS Szemészeti pamut vatta 200 g-os IZIS100200SZ
EUDAMED
Class IActive
IZIS Fix Rugalmas csőhálókötszer 9-es méret 5 m CSFIX0905
EUDAMED
Class IActive
IZIS Fix Rugalmas csőhálókötszer 10-es méret 25 m 302510UJ22/10/20
EUDAMED
Class IActive

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