Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1000312731

FEI Number

1000312731

Entity Name

BELLCO Srl

City/State/Country

Mirandola Modena, IT

Establishment Address

via Camurana, 1, Mirandola Modena 41037, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Mozarc Medical US LLC (Owner Number: 10090982)

Owner / Operator Contact Address

15 Hampshire Street, Mansfield, MA 02048, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K193542

PMA Number

N/A

All Registered Proprietary Names

3L NON-STERILE WASTE BAGS FOR CARPEDIEM US CARPEDIEM System Clearum HS dialyzers

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NNW	Bag, Urine Collection, Leg, For External Use, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2024-12-11
LGZ	Warmer, Thermal, Infusion Fluid	General Hospital	Class 2	880.5725	2024-07-31
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2024-07-31
QIR	Pediatric Hemodialysis System	Gastroenterology, Urology	Class 2	876.5861	2024-12-11
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2024-07-31

Official Correspondent

No official correspondent registered.

US Agent Details

Carol Ming Business: Mozarc Medical US LLC Email: carol.ming@mozarcmedical.com Phone: (774) 2910767

Related Public Records

Same Entity

Mozarc Medical US LLC

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3043804021	Mozarc Medical Italy	Mirandola Modena, IT
3030574705	MOZARC MEDICAL US LLC	Mansfield, MA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12
K811830	Cordis Corp.	C-DAK DUO-FLUX ARTIFICIAL KIDNEY	1981-09-21
K070320	Edwards Lifesciences Services GmbH	EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01	2007-06-07
K150880	Outset Medical	Tablo Console with Wireless Capability	2015-05-01

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

Similar Registrations

Registration Number	Establishment Name	Location
3004472848	VELCRO (CHINA) FASTENING SYSTEMS COMPANY LIMITED	ZHANGJIAGANG Jiangsu, CN
3016577639	ACOSTA MEDICAL GROUP INC.	Houston, TX, US
3014615175	K-MED CO., LTD.	Yangzhou Jiangsu, CN
8022890	VALENTINE INTL. LTD.	HSICHIH CITY, TAIPEI HSIEN, TW
3013187142	ENDURE INDUSTRIES, INC.	Homer, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000312731. Last updated year: 2026. Please use registration number 1000312731 when referencing this establishment in official correspondence.