Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012656745

FEI Number

3012656745

Entity Name

HENBOR DI GIANOLA ANTONIO & BIAGIO SNC

City/State/Country

Premana Lecco, IT

Establishment Address

VIA ROMA 47, Premana Lecco 23834, IT

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

HENBOR DI GIANOLA ANTONIO & BIAGIO SNC (Owner Number: 10052147)

Owner / Operator Contact Address

VIA ROMA 47, Premana, IT-LC 23834, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Surgical Instruments Elevators scalpel handles Surgical Scissors General Instruments

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2016-06-21
HTE	Elevator	General, Plastic Surgery	Class 1	878.4800	2016-06-21
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2018-11-23
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2016-06-21
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2016-09-08

Official Correspondent

No official correspondent registered.

US Agent Details

Earl Bautista Email: earl.bautista24@yahoo.com Phone: (904) 5026434

Related Public Records

Same Entity

HENBOR DI GIANOLA ANTONIO & BIAGIO SNC

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
K851170	The Huxley Instrument Corp.	DISSECTING TWEEZER #283-72PCS. SS 410	1985-04-25
K821248	Conphar, Inc.	ROCHESTER PEAN FORCEPS	1982-05-28

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0039-2018	Teleflex Medical	1	Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.

Similar Registrations

Registration Number	Establishment Name	Location
3005374323	SPECTRUM SURGICAL SUPPLIES	SIALKOT Punjab, PK
3043226252	ZAPALIGN LLC	Fort Lauderdale, FL, US
3035678069	MATTES INSTRUMENTE GMBH	Tuttlingen-Nendingen Baden-Wurttemberg, DE
1421879	PHOENIX INSTRUMENTS, INC.	Lisle, IL, US
1123010	TRINITY STERILE, INC.	SALISBURY, MD, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012656745. Last updated year: 2026. Please use registration number 3012656745 when referencing this establishment in official correspondence.