Ab Fatex Oy
Finland FI-MF-000018305 Last updated 21 Oct 2026
- Devices
- 11
- Registries
- EUDAMED
- FDA recalls
- 0
Catalogue
About
Fatex is a company founded in 1973 and located in Kronoby, Finland. We are specialized in manufacturing of disposable products for patient care such as protection sheets, bibs, wipes and wash-gloves. All of our products are high quality and we hold 14001 environment, 9001 quality and 13485 medical device certificates. Most of our products are exported to Europe. Together with our customers we try to work out the best solutions according to the customers wishes.
What Ab Fatex Oy makes
Ab Fatex Oy manufactures single-use patient care products, including disposable protection sheets, bibs, and wipes designed for hygiene and contamination control. Their offerings include underlay protection sheets in various sizes, bibs with different ply counts, and specialized protective sheets for medical environments. Additional items include wash-gloves and knitted lap covers for patient comfort and safety.
All products fall under Class I medical device classification and are registered in the EUDAMED database. The company is based in Finland and adheres to regulatory requirements for non-invasive, low-risk devices under EU medical device legislation.
Frequently asked questions
What types of medical devices does Ab Fatex Oy manufacture?
Ab Fatex Oy specializes in disposable patient care products primarily focused on hygiene and contamination control. Their portfolio includes protection sheets (such as underlay and specialized variants), bibs with varying ply counts, knitted lap covers, and wash-gloves. These items are designed for single-use in medical settings to minimize infection risk and ensure patient comfort.
Where is Ab Fatex Oy based, and what regulatory database lists its devices?
Ab Fatex Oy is headquartered in Kronoby, Finland. Their devices are registered in the EUDAMED database, which is the official European Union registry for medical devices. This listing ensures transparency and compliance with EU medical device regulations.
How are Ab Fatex Oy’s devices classified under EU medical device regulations?
All of Ab Fatex Oy’s devices fall under Class I classification in the EU. This classification applies to low-risk, non-invasive products like disposable patient care items (e.g., protection sheets, bibs, and wash-gloves), which pose minimal risk to patients and users. Class I devices typically require basic conformity assessment procedures, such as self-certification by the manufacturer.
Are Ab Fatex Oy’s devices intended for reuse, or are they designed for single-use?
Ab Fatex Oy’s devices are explicitly designed for single-use in patient care settings. Products like protection sheets, bibs, and wash-gloves are manufactured as disposable items to prevent cross-contamination and maintain hygiene standards in medical environments.
Information
- Country
- Finland
- Address
- 1, Företagarvägen , Kronoby, Finland
- Website
- www.fatex.fi
- [email protected]
- Phone
- +358400269355
- PRRC contact
- Tom Nylund
- EUDAMED SRN
- FI-MF-000018305