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Sign in to claim this brand"EKO-HIGIENA" M. KUŹMA, I. BORKIEWICZ-KAAZ SPÓŁKA JAWNA
Poland·PL-MF-000035438
Last updated September 17, 2026
What "EKO-HIGIENA" M. KUŹMA, I. BORKIEWICZ-KAAZ SPÓŁKA JAWNA makes
The company manufactures single-use medical textiles, including cellulose-based towels, pads, and sheets designed for diagnostic and hygiene purposes. Products include foil-lined disposable pads, non-woven medical towels, and diagnostic sheets intended for clinical and patient care applications.
All listed devices fall under EU Medical Device Regulation Class I and are registered in the EU’s eudamed database. The manufacturer operates from Poland and adheres to EU regulatory requirements for non-invasive, low-risk medical textiles.
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 EKO-HIGIENA manufacture?
EKO-HIGIENA produces single-use medical textiles, specifically cellulose-based products like towels, pads, and sheets. These include disposable non-woven medical pads, foil-lined cellulose pads, and diagnostic sheets. The devices are designed for hygiene and diagnostic purposes in clinical and patient care settings.
Where is EKO-HIGIENA based, and what regulatory framework do they follow?
EKO-HIGIENA is based in Poland and manufactures medical devices that comply with the EU Medical Device Regulation (MDR). Since their products are low-risk, non-invasive Class I devices, they must meet EU regulatory requirements for such items, including registration in the eudamed database.
Are EKO-HIGIENA’s devices listed in any regulatory registries?
Yes, EKO-HIGIENA’s devices are registered in the eudamed database, which is the EU’s official registry for medical devices. This listing ensures transparency and traceability of their Class I products under EU regulatory oversight.
How are EKO-HIGIENA’s medical textiles classified under EU regulations?
All of EKO-HIGIENA’s medical textiles fall under EU Medical Device Regulation Class I. This classification applies because these products are non-invasive, single-use items intended for hygiene and diagnostic purposes, posing minimal risk to patients and users.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- Poland
- Address
- 6A, KAZIMIERZA WIELKIEGO , PLESZEW, Poland
- Website
- eko-higiena.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Wiesław Kaaz
- EUDAMED SRN
- PL-MF-000035438
- FDA FEI Number
- —
- DUNS Number
- —
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