Data / Medical devices / Italy / Medica S.p.A.

Medica S.p.A.: FDA-registered device maker in Medolla Modena, Italy, 9 510(k) clearances

Name: Medica S.p.A. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Medica S.p.A. is registered with the FDA (registration 9615942) in Medolla Modena, Italy. It lists 6 device types. The FDA files 9 510(k) clearances under its listings, the newest dated February 7, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 9615942
FEI number: 1000191953
Address: via degli Artigiani, 7, Medolla Modena, Italy, 41036
Owner or operator: Medica S.p.A. (9040626)
Roles: Complaint file establishment, Contract manufacturer, Specification developer
First device listed: March 7, 2012
Registered through: 2026
Brand names listed: Carpediem - preassembled disposable device, DSU-D UltraFilter; SSU-D UltraFilter; SSUmini JG UltraFilter; SSUmini UltraFilte, DSU-H UltraFilter; SSU-H UltraFilter, EndoPur Endotoxin 10 Filter; EndoPur Endotoxin 20 Filter; EndoPur Endotoxin 30 Filter, FiberFlo, HEMOCOR HPH MINI HEMOCONCENTRATOR, HPH Junior - High Performance Hemoconcentrator, Hemocor HP Hemoconcentrator - HP700 + TS and more

Devices it lists

Device	Product code	Class	Role	Source
Device, Cystometric, Hydraulic	FEN	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Dialyzer, High Permeability With Or Without Sealed Dialysate System	KDI	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant	SGY	2	Contract manufacturer	accessdata.fda.gov
Pediatric Hemodialysis System	QIR	2	Contract manufacturer	accessdata.fda.gov
Subsystem, Water Purification	FIP	2	Complaint file establishment, Contract manufacturer, Specification developer	accessdata.fda.gov
System, Water Purification, General Medical Use	NHV	2	Contract manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
February 7, 2024	K232171	Purema® H Hemoconcentrator (EtO Sterilized)	KDI	Substantially Equivalent	Tecnoideal America	accessdata.fda.gov
January 31, 2006	K050952	HPH JUNIOR HIGH PERFORMANCE HEMOCONCENTRATOR	KDI	Substantially Equivalent	Minntech Corp.	accessdata.fda.gov
April 4, 2000	K000028	RENAFLO II HF 2000 HEMOFILTER	KDI	Substantially Equivalent	Minntech Corp.	accessdata.fda.gov
March 8, 1999	K983126	FIBERFLO HOLLOW FIBER CAPSULE WATER FILTERS	FIP	Substantially Equivalent	Minntech Corp.	accessdata.fda.gov
November 13, 1998	K983085	HEMOCOR HPH 700 HEMOCONCENTRATOR	KDI	Substantially Equivalent	Minntech Corp.	accessdata.fda.gov
May 12, 1998	K980859	HEMOCOR HPH MINI HEMOCONCENTRATOR	KDI	Substantially Equivalent	Minntech Corp.	accessdata.fda.gov
December 15, 1995	K954349	FIBERFLO HOLLOW FIBER CARTRIDGE WATER FILTERS	FIP	Substantially Equivalent	Minntech Corp.	accessdata.fda.gov
February 18, 1994	K923312	HIGH PERMEABILITY DIALYER	KDI	Substantially Equivalent	Minntech Corp.	accessdata.fda.gov
February 18, 1994	K923139	HEMOCOR HP HEMOCONCENTRATOR SERIES	KDI	Substantially Equivalent	Minntech Corp.	accessdata.fda.gov

Compare with other makers

Updated February 7, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.