Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006680097

FEI Number

3006680097

Entity Name

THD SPA

City/State/Country

Correggio Reggio Emilia, IT

Establishment Address

Via per Carpi, 15/B, Correggio Reggio Emilia 42015, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

THD SpA (Owner Number: 10025818)

Owner / Operator Contact Address

Via per Carpi, 15/B, Correggio, IT-RE 42015, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

THD Evolution USB Probe, ER12MHZ THD EAUS PROBE 12 MHZ THD DIGITAL MOBILE ECOGRAPHY THD DIGITAL MOBILE ADVANCED THD PRESSPROBE (ENV 200) THD PRESSPROBE (BOX) THD PRESSPROBE (ENV 100) THD PRESSKIT (TR ENV 100) THD PRESSPROBE (BOX 10) THD PRESSKIT (TR ENV 50) THD PRESSPROBE (ENV 50) THD PRESSKIT (TR BOX 10) THD PRESSPROBE (ENV) THD PRESSKIT (TR ENV) THD PRESSKIT (FL ENV 100) THD PRESSKIT (FL BOX) THD ANOPRESS THD PRESSKIT (FL BOX 10) THD PRESSKIT (TR BOX) THD PRESSKIT (TR ENV 200) THD PRESSKIT (FL ENV 200) THD PRESSKIT (FL ENV 50) THD PRESSKIT (FL ENV) THD MINI-RECTO (NS) THD MAXI-RECTO (NS) THD N-ANO MAXI (TR) THD N-ANO MAXI (BE) THD N-ANO (TR) THD N-ANO DIGITAL MAXI (TR) THD N-ANO (BE) THD N-ANO DIGITAL MAXI (BE) THD N-ANO DIGITAL (TR) THD N-ANO DIGITAL (BE) THD S-ANO (BE/NS) THD M-ANO (BE/NS) THD L-PROCTO (TR/NS) THD L-PROCTO (BE/NS) THD L-ANO (TR/NS) THD S-ANO (BE/ST) THD S-ANO (TR/NS) THD M-ANO (TR/ST) THD M-PROCTO (BE/ST) THD SURGY MINI (ST) THD M-ANO (BE/ST) THD M-PROCTO (TR/NS) THD M-ANO (TR/NS) THD L-ANO (BE/NS) THD M-PROCTO (BE/NS) THD S-ANO (TR/ST) THD L-ANO (BE/ST) THD L-ANO (TR/ST) THD SURGY MAXI (ST) THD BIOPSY (J) THD BIOPSY (GI - XL) THD BIOPSY (GI) Daisy, Maestro THD Bandy THD REVOLUTION THD REVOLUTION ACCESSORIES PACK US THD OPTI-FIBER (REVO/BT) THD REVOLUTION US THD DOPPLER PROBE (1s/ST) THD OPTI-FIBER (EVO/BT) THD EVOLUTION ACCESSORIES PACK US THD ANOLIFT US THD OPTI-FIBER (EVO/BT-880002) THD OPTI-FIBER (EVO/CA) THD SLIDE ONE USA THD EVOLUTION WITH ACCESSORIES THD SLIDE THD EVOLUTION US THD RE-NEEDHOLD (NS) THD LIGHT-SCOPE RECTO MAXI (LED INS/NS) THD LIGHT-SCOPE ANO (BE/NS) THD LIGHT-SCOPE MAXI-RECTO (INS/NS) THD LIGHT-SCOPE MINI-RECTO (NS) THD LIGHT-SCOPE ANO (TR/NS) THD LIGHT-SCOPE ANO (LED BE/NS) THD LIGHT-SCOPE RECTO MINI (LED NS) THD LIGHT-SCOPE MINI-RECTO (INS/NS) THD LIGHT-SCOPE SURGY MINI (NS) THD LIGHT-SCOPE MAXI-RECTO (NS) THD LIGHT-SCOPE RECTO MINI (LED INS/NS) THD LIGHT-SCOPE ANO (LED TR/NS) THD LIGHT-SCOPE RECTO MAXI (LED NS) Inflation Bulb THD LIGHT-SCOPE MINI-RECTO (NS) THD LIGHT-SCOPE MAXI-RECTO (LED INS/ST) THD LIGHT-SCOPE RECTO MAXI (LED NS) THD SURGY MAXI (ST) THD LIGHT-SCOPE SURGY MINI (NS) THD LIGHT-SCOPE ANO (LED BE/NS) THD LIGHT-SCOPE ANO (TR/NS) THD M-PROCTO (BE/ST) THD L-ANO (BE/NS) THD LIGHT-SCOPE MAXI-RECTO (ST) THD M-ANO (TR/ST) THD LIGHT-SCOPE SURGY MAXI (LED ST) THD L-ANO (TR/NS) THD L-ANO (TR/ST) THD LIGHT-SCOPE MAXI-RECTO (LED ST) THD LIGHT-SCOPE ANO (BE/ST) THD M-ANO (BE/ST) THD S-ANO (TR/ST) THD LIGHT-SCOPE MAXI-RECTO (INS/NS) THD LIGHT-SCOPE MINI-RECTO (LED INS/ST) THD LIGHT-SCOPE ANO (TR/ST) THD LIGHT-SCOPE MINI-RECTO (INS/NS) THD LIGHT-SCOPE ANO (LED BE/ST) THD LIGHT-SCOPE ANO (LED TR/NS) THD L-PROCTO (BE/NS) THD LIGHT-SCOPE SURGY MINI (LED ST) THD LIGHT-SCOPE MINI-RECTO (LED ST) THD M-ANO (BE/NS) THD LIGHT-SCOPE MAXI-RECTO (INS/ST) THD LIGHT-SCOPE MINI-RECTO (INS/ST) THD LIGHT-SCOPE ANO (LED TR/ST) THD LIGHT-SCOPE RECTO MINI (LED NS) THD M-ANO (TR/NS) THD LIGHT-SCOPE RECTO MAXI (LED INS/NS) THD SURGY MINI (ST) THD L-PROCTO (TR/NS) THD LIGHT-SCOPE MAXI-RECTO (NS) THD LIGHT-SCOPE MINI-RECTO (ST) THD LIGHT-SCOPE RECTO MINI (LED INS/NS) THD LIGHT-SCOPE PROCTO HRA THD M-PROCTO (BE/NS) THD L-ANO (BE/ST) THD S-ANO (TR/NS) THD M-PROCTO (TR/NS) THD S-ANO (BE/NS) THD MINI-RECTO (NS) THD S-ANO (BE/ST) THD LIGHT-SCOPE ANO (BE/NS) THD MAXI-RECTO (NS) THD 4K CAM THD DIGITAL MINICAM

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JAF	Monitor, Ultrasonic, Nonfetal	Radiology	Class 2	892.1540	2008-08-01
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2021-07-16
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2021-07-16
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2021-07-16
NEW	Suture, Surgical, Absorbable, Polydioxanone	General, Plastic Surgery	Class 2	878.4840	2025-03-11
KLA	Monitor, Esophageal Motility, Anorectal Motility, And Tube	Gastroenterology, Urology	Class 2	876.1725	2017-03-16
FER	Anoscope And Accessories	Gastroenterology, Urology	Class 2	876.1500	2009-11-10
FER	Anoscope And Accessories	Gastroenterology, Urology	Class 2	876.1500	2014-12-09
GCP	Endoscope, Ac-Powered And Accessories	Gastroenterology, Urology	Class 2	876.1500	2014-12-09
FER	Anoscope And Accessories	Gastroenterology, Urology	Class 2	876.1500	2008-05-12
GCF	Proctoscope	Gastroenterology, Urology	Class 2	876.1500	2008-05-12
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2024-10-21
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2017-07-12
FHN	Ligator, Hemorrhoidal	Gastroenterology, Urology	Class 2	876.4400	2012-02-07
JAF	Monitor, Ultrasonic, Nonfetal	Radiology	Class 2	892.1540	2015-05-13
JAF	Monitor, Ultrasonic, Nonfetal	Radiology	Class 2	892.1540	2009-03-11
FER	Anoscope And Accessories	Gastroenterology, Urology	Class 2	876.1500	2011-04-11
FCY	Bulb, Inflation, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2010-11-12
FER	Anoscope And Accessories	Gastroenterology, Urology	Class 2	876.1500	2012-08-20
GCP	Endoscope, Ac-Powered And Accessories	Gastroenterology, Urology	Class 2	876.1500	2012-08-20
FWF	Camera, Television, Endoscopic, Without Audio	General, Plastic Surgery	Class 1	878.4160	2022-11-03

Official Correspondent

Filippo Bastia

US Agent Details

Filippo bastia Business: THD America Inc. Email: filippo.bastia@thdlab.com Phone: (866) 3749442

Related Public Records

Same Entity

THD 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
K010521	Nicolet Biomedical	NICOLET VERSALAB	2001-03-09
K191007	Supersonic Imagine	Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems	2019-10-25
K974588	Rimed , Ltd.	INTRA-VIEW BILATERAL TRANSCRANIAL DOPPLER DEVICE, SMART-LITE PORTABLE BILATERAL TRANSCRANIAL DOPPLER DEVICE, COMPACT MOD	1998-08-07
K142628	Siemens Medi Cal Solutions, Inc.	Acuson SC2000 Diagnostic Ultrasound System	2014-10-10
K132171	Supersonic Imagine	AIXPLORER	2013-09-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0189-2022	FujiFilm Healthcare Americas Corporation	2	Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3
Z-0190-2022	FujiFilm Healthcare Americas Corporation	2	Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3
Z-0191-2022	FujiFilm Healthcare Americas Corporation	2	Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3
Z-0192-2022	FujiFilm Healthcare Americas Corporation	2	Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0
Z-1884-2024	FUJIFILM Healthcare Americas Corporation	2	Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006680097. Last updated year: 2026. Please use registration number 3006680097 when referencing this establishment in official correspondence.