HomeItalyCeracarta S.p.A.

Ceracarta S.p.A.

Italy · Forli (FC) · ceracarta.it
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Saudi Arabia, Taiwan, Australia, Israel, Russia — 7 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
0UDI-DI device records
USUnited StatesFDA openFDA
2listed device types
Class I 1Class II 1Class III 0
plus 2 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
2registered devices
Class I 2
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
1registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
1valid device licences
Class I 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
4active ARTG entries
Class I 2IIa 1Class Is (sterile) 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
RURussiaRoszdravnadzor
3active registrations
Class 1 3
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States2 registration records, 1 510(k), 0 PMA
Brazil2 confirmed, 0 excluded
Saudi Arabia1 confirmed, 1 excluded
Manufacturer names merged into this page: CERACARTA SPA · Ceracarta S.p.A.

Company information

Country
Italy
City
Forli (FC)
Website
ceracarta.it
Product categories
Clinical Diagnostics & Therapeutic TechnologiesDiagnostics, Imaging & Nuclear MedicineRadiology & Imaging SystemsUltrasound (POCUS, AI-guided, portable)Medical Devices & Clinical EquipmentCardiology & vascular medicineIntegrated Care, Rehabilitation & HomecareConsumables, disposables & infection control

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Legal name
CERACARTA - S.P.A.
LEI
81560065621E9BE98893
Registration status
Active
Legal form
Società Per Azioni (SPA)
Incorporated
1960-06-07
Registered address
SECONDO CASADEI, 14 (ZONA IND.LE VILLASELVA), FORLI', 47122
Registration authority
Business Register, no. 00136740404
Registry record updated
2026-06-17

Business registration data from GLEIF, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

12010 · K101429

FDA listed device types

System, Imaging, Pulsed Echo, Ultrasonic 1Recorder, Paper Chart 1

Registration details (sample)

MarketIdentifierNameClass / date
USK101429ECO SUPERGEL2010-09-15
BR81937610001ELETRODOS ECG TOP TRACEClass I
BR81937610003Eletrodos ECG Medi SensorClass I
SAME0000006338SFDAA00001TopTrace

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