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Sign in to claim this brandEUROCOSMETIC 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
- —
- facebook.com/Izis-333924520359260
- [email protected]
- Phone
- +40723164556
- PRRC Contact
- Károly Tordai
- EUDAMED SRN
- RO-MF-000000906
- FDA FEI Number
- —
- DUNS Number
- —
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