Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008506949

FEI Number

3008506949

Entity Name

CERACARTA SPA

City/State/Country

Forli, IT

Establishment Address

Secondo Casadei,14, Forli 47122, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

CERACARTA SPA (Owner Number: 10033758)

Owner / Operator Contact Address

Secondo Casadei,14, Forli, IT-FC 47122, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K101429

PMA Number

N/A

All Registered Proprietary Names

RECORDING PAPER AND RECORDING CHART PAPER ECO SUPERGEL ECO SUPERGEL CLEAR

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DSF	Recorder, Paper Chart	Cardiovascular	Class 1	870.2810	2010-09-28
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2010-09-28

Official Correspondent

Francesca Tanfi

US Agent Details

ELAINE DUNCAN Business: PALADIN MEDICAL Inc. Email: duncan@paladinmedical.com Phone: (715) 5496035

Related Public Records

Same Entity

CERACARTA SPA

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
K770946	Instrumentation Laboratory CO	RECORD, MODEL 702, I.L.	1977-07-05
K882805	Coopervision-Cilco	CILCO VILLASENOR PACHYMETER	1988-08-12
K791040	Shimadzu Corp.	SECTOR SCANNER, SDU-100, COMPUTERIZED	1979-10-04
K162372	Qt Ultrasound, LLC	QT Ultrasound Breast Scanner-1	2017-06-06
K930964	Acuson Corp.	ACUSON MODEL #29001 (DIAGNOSTIC ULTRASOUND DEVICE)	1994-10-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-2011	Verathon, Inc.	2	BVI 9600 Bladder Volume Instrument, Aorta Scan Mode The BladderScan BVI 9600 with AortaScan Mode is a user-selectable, dual-function ultrasound device that projects ultrasound energy either into the lower abdomen to obtain an image of the bladder for measuring bladder volume, or into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements.
Z-0004-2011	Verathon, Inc.	2	AortaScan AMI 9700 The AortaScan AMI 9700 is an ultrasound device that projects ultrasound energy into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements
Z-0005-2011	Verathon, Inc.	2	BladderScan BVM 9500 The BladderScan BVM 9500 is intended to project ultrasound energy through the lower abdomen to obtain an image of the bladder and measure urinary bladder volume and mass noninvasively.
Z-0027-2014	SonoSite, Inc.	2	P21x/5-1 MHz transducer, Part Number P07698-23 Product Usage: The P21x/5-1 MHz phased array transducer is designed for cardiac, abdominal and obstetric, TCD and orbital exams. It supports 2D with SonoMB Multi Beam Technology and Auto Gain capabilities, SonoHD Imaging Technology, Tissue Harmonic Imaging, M-Mode, Velocity Color Flow Doppler, Color Power Doppler (CDP), Pulsed Wave (PW), TDI Pulsed Wave, and Continuous Wave Doppler.

Similar Registrations

Registration Number	Establishment Name	Location
3002519582	BLUMBERG GMBH & CO. KG	Ratingen North Rhine-Westphalia, DE
9610816	Philips Medizin Systeme Boeblingen GmbH	BOEBLINGEN Baden-Wurttemberg, DE
3032916632	BECTON, DICKINSON AND COMPANY	Irvine, CA, US
3016701404	Philips North America LLC	Export, PA, US
3008729547	GE Medical Systems Information Technologies - Critikon de Mexico S. de R.L. de C.V.	JUAREZ Chihuahua, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008506949. Last updated year: 2026. Please use registration number 3008506949 when referencing this establishment in official correspondence.