Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013058659

FEI Number

3013058659

Entity Name

REDAX S.P.A

City/State/Country

Poggio Rusco Mantova, IT

Establishment Address

Via Galileo Galilei 18, Poggio Rusco Mantova 46025, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Redax S.p.A (Owner Number: 10052065)

Owner / Operator Contact Address

Via Galileo Galilei 18, Poggio Rusco, IT-MN 46025, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2016-06-10
GBP	Catheter, Multiple Lumen	General, Plastic Surgery	Class 1	878.4200	2021-03-22
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2020-02-28

Official Correspondent

Andrea Gibertoni

US Agent Details

Christian Costantini Business: MACLIN POWER INC. Email: sales@maclinmed.com Phone: (786) 8187337

Related Public Records

Same Entity

Redax S.p.A

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K883982	Iberhospitex, S.A.	DRENOVAC	1989-02-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-04	Vital Concepts, Inc.	1	Huntington Instruments brand Irrigation Aspiration System with Single Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55040. Labeled as Manufactured for Huntington Instruments, Ogden Utah.
Z-0021-04	Vital Concepts, Inc.	1	Irrigation Aspiration System with Double Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55060. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan. Huntington Instruments brand labeled as Manufactured for Huntington Instruments, Ogden Utah. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ. Catalogue # 55060-10 sold in Canada and labeled as Manufactured for Jac-Cell Medic, Dorval, Quebec.
Z-0022-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Irrigation Aspiration System with double Spike Tubing, no Probe, Disposable (single use only), sterile, latex free. Catalog # 55160. Vital Concepts, Inc., Grand Rapids, Michigan.
Z-0023-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Suction-Irrigation System without Probe, Disposable (single use only), sterile, latex free. R-Med Re-Order # 55170R; Distributed by R-Med, Inc., Orgeon, OH
Z-0024-04	Vital Concepts, Inc.	1	Quanta Technologies L.L.C. brand REORDER # LAPKIT 3. Contents 1 -55060 Suction/Irrigation Valve 2- 30012 Insufflation Tubing set 3- 5010 Anti Fog Solution with Sponge. Manufactured for Quanta Technologies, L.L.C., Tucson, AZ.

Similar Registrations

Registration Number	Establishment Name	Location
3017101761	IC SURGICAL INC	Grand Rapids, MI, US
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3013025177	Phillips-Medisize Healthcare (Suzhou) CO., LTD	Suzhou Jiangsu, CN
1416980	BAXTER HEALTHCARE CORPORATION	ROUND LAKE, IL, US
3026986849	FANSHENG TECHNOLOGY (GUANGDONG) CO., LTD .	Zhongshan City Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013058659. Last updated year: 2026. Please use registration number 3013058659 when referencing this establishment in official correspondence.