Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004960482

FEI Number

3004960482

Entity Name

ELCAM MEDICAL ITALY SPA

City/State/Country

CARPI Modena, IT

Establishment Address

15, VIA EMILIA-ROMAGNA, CARPI Modena 41012, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ELCAM MEDICAL ITALY SPA (Owner Number: 9094403)

Owner / Operator Contact Address

15, VIA EMILIA-ROMAGNA, --, CARPI, IT-MO 41012, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K852605

PMA Number

N/A

All Registered Proprietary Names

7001-3926 - INJECTION SITE 175IBLSSC - CATHETHER INJECTION PORT 07103300/S - RECIRCULATION FLL CONNECTOR WITH VENTED CAP 7001-3915 - NON INJECTABLE CATHETER CAP 7001-3902W - RECIRCULATION CONNECTOR

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GCE	Adaptor, Catheter	General, Plastic Surgery	Class 1	878.4200	2006-11-08
FJK	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	Gastroenterology, Urology	Class 2	876.5820	2006-11-08

Official Correspondent

Chiara Candini

US Agent Details

Tomer Gil Business: ELCAM MEDICAL INC. Email: Tomer@Elcam.Co.Il Phone: (201) 4571120

Related Public Records

Same Entity

ELCAM MEDICAL ITALY SPA

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3020707080	FUJIFILM medwork GmbH	Hochstadt/Aisch Bavaria, DE
1018233	C.R. BARD, INC.	COVINGTON, GA, US
3013526170	Jiangsu Vedkang Medical Science and Technology Co.,Ltd.	Changzhou Jiangsu, CN
3013440400	Micro-Tech (Nanjing) Co., Ltd.	Nanjing Jiangsu, CN
2124215	Boston Scientific Corporation	Saint Paul, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004960482. Last updated year: 2026. Please use registration number 3004960482 when referencing this establishment in official correspondence.