Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003905499

FEI Number

3003905499

Entity Name

QUALITEAM S.R.L.

City/State/Country

Burolo Piedmont, IT

Establishment Address

Via Torino 12, Burolo Piedmont 10010, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

QUALITEAM s.r.l. (Owner Number: 9075149)

Owner / Operator Contact Address

Via Torino 12, --, Burolo, IT-TO 10010, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Calla hot/cold pack QualiBelly QualiBelly Advanced QualiBra QualiBra Advanced INVOGUARD Legband LineGuard Headband LineGuard Legband INVOHALO Headband Thor chest binder

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2018-12-27
FSD	Binder, Abdominal	General Hospital	Class 1	880.5160	2009-12-10
KTD	Orthosis, Abdominal	Physical Medicine	Class 1	890.3490	2012-03-28
HEF	Binder, Breast	General Hospital	Class 1	880.5160	2010-12-22
KRI	Accessory Equipment, Cardiopulmonary Bypass	Cardiovascular	Class 1	870.4200	2023-09-04
IPT	Orthosis, Thoracic	Physical Medicine	Class 1	890.3490	2008-03-05

Official Correspondent

Doris Hjorth

US Agent Details

Michael Crawford Business: Med Alliance Group Email: mcrawford@medalliancegroup.com Phone: (630) 4437070

Related Public Records

Same Entity

QUALITEAM s.r.l.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003905499. Last updated year: 2026. Please use registration number 3003905499 when referencing this establishment in official correspondence.