Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013500854

FEI Number

3013500854

Entity Name

BETATEX S.P.A.

City/State/Country

Ospedalicchio di Bastia Umbra Perugia, IT

Establishment Address

Viale Europa - Zona Industriale, Ospedalicchio di Bastia Umbra Perugia 06080, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BETATEX S.P.A. (Owner Number: 10053158)

Owner / Operator Contact Address

Via Raffaello 2, Assisi, IT-PG 06081, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

surgical drapes

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ERY	Drape, Surgical, Ent	General, Plastic Surgery	Class 2	878.4370	2020-01-31

Official Correspondent

Eleonora Tarpanelli

US Agent Details

Emily Matorin Email: usagent@fdabasics.com Phone: (716) 7750533

Related Public Records

Same Entity

BETATEX S.P.A.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3030220356	SUZHOU SHANGCHUANG TECHNOLOGY SERVICE CO., LTD.	Suzhou Jiangsu, CN
1423537	Cardinal Health 200, LLC	Waukegan, IL, US
3005391805	ATLANTA HEALTHCARE SERVICES	Lawrenceville, GA, US
3016874083	HANH MINH MANUFACTURING TRADING COMPANY LIMITED	Bien Hoa Dong Nai, VN
3010160370	Hebei Ruinuo Medical Instrument Co Ltd	Shijiazhuang Hebei, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013500854. Last updated year: 2026. Please use registration number 3013500854 when referencing this establishment in official correspondence.