Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004443374

FEI Number

3004443374

Entity Name

SAPI MED S.P.A

City/State/Country

ALESSANDRIA, IT

Establishment Address

Via della Chimica 6 - Z. I. D3, ALESSANDRIA 15121, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SAPI MED S.P.A (Owner Number: 9060655)

Owner / Operator Contact Address

Via della Chimica, 6, Z.I. D3, ALESSANDRIA, IT-AL 15121, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

GLF 100 LEM - Suction hemorrhoidal ligator LEM - Traction banding ligator LEM - Suction banding ligator LEM Traction hemorrhoidal ligator LEM - Disposable banding ligator LEM - Self-Suction LEM 4 Rings Procto-sigmoidoscope Pediatric Procto-sigmoidoscope with Grip Proctoscope Short Rigid Procto-sigmoidoscope Kit MRP Ecolite Pen LED Light SELF-LIGHT - Adult Anoscope THE BEAK LIGHTED RETRACTOR BASILE'S CONE RETRACTOR SELF-LIGHT - Pediatric Anoscope SELF-LIGHT - Therapeutic Anoscope Cylindrical operative anal retractr L-Bet88 Dilastom Dilatan Dilatan Plus

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FEM	Accessories, Photographic, For Endoscope (Exclude Light Sources)	Gastroenterology, Urology	Class 1	876.1500	2004-01-15
FHN	Ligator, Hemorrhoidal	Gastroenterology, Urology	Class 2	876.4400	2007-12-16
KDM	Sigmoidoscope, Rigid, Non-Electrical	Gastroenterology, Urology	Class 2	876.1500	2007-12-16
NTN	Led Light Source	Gastroenterology, Urology	Class 2	876.1500	2016-04-05
FER	Anoscope And Accessories	Gastroenterology, Urology	Class 2	876.1500	2007-12-16
FFP	Dilator, Rectal	Gastroenterology, Urology	Class 1	876.5450	2004-01-15

Official Correspondent

Paola Oddenino

US Agent Details

Brian Chandler Business: CEO Adler MicroMed Email: bchandler@adlermicromed.com Phone: (484) 9957919

Related Public Records

Same Entity

SAPI MED S.P.A

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
K940152	Hydro-Med Products, Inc.	CAMERA COVER WITH TEAR TIP	1994-10-28
K000397	Boston Scientific Corp	SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228; INJECTION SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODEL	2000-03-07

Similar Registrations

Registration Number	Establishment Name	Location
3033043422	NOVANTA MEDICAL S.R.O.	Prelouc Pardubicky Kraj, CZ
3012843412	BRITEMED TECHNOLOGY INC.	New Taipei City, TW
3003782610	HOYA Corporation PENTAX Lifecare Division	KURIHARA-SHI Miyagi, JP
9610617	KARL STORZ SE & CO. KG	TUTTLINGEN Baden-Wurttemberg, DE
3011459664	QINGDAO O-MEC MEDICAL TECHNOLOGY CO., LTD.	Qingdao Shandong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004443374. Last updated year: 2026. Please use registration number 3004443374 when referencing this establishment in official correspondence.