Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003675041

FEI Number

3003675041

Entity Name

SURGICAL INSTRUMENTS BELGIUM SA

City/State/Country

GEMBLOUX Namur, BE

Establishment Address

Rue du Gaillard 5, GEMBLOUX Namur 5030, BE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SURGICAL INSTRUMENTS BELGIUM SA (Owner Number: 9049892)

Owner / Operator Contact Address

Rue du Gaillard 5, Gembloux, BE-WNA 5030, BE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

FORCEPS FORCEPS CLAMP ORTHOPEDIC RETRACTOR RETRACTOR SPECULUM SIBEL 3003675041 Pilling SIBEL CURETTE SIBEL 3003675041 Vascular Clamp FORCEPS MICRO NEEDLEHOLDER SCISSORS Sibel SIBEL

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2002-02-25
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2002-02-25
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2002-02-25
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2002-02-25
KAG	Holder, Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	2002-02-25
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2013-02-19
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2002-02-25
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	Class 1	878.4800	2016-11-24
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	2007-04-05
HRQ	Hemostat	General, Plastic Surgery	Class 1	878.4800	2013-02-19
FZS	Curette, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2002-02-25
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2013-02-19
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2002-02-25
HAO	Instrument, Surgical, Non-Powered	Neurology	Class 1	882.4535	2002-02-25
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2008-12-01
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2002-02-25
GZX	Instrument, Microsurgical	Neurology	Class 1	882.4525	2007-04-05
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2002-02-25
HXK	Holder, Needle; Orthopedic	Orthopedic	Class 1	888.4540	2013-02-19

Official Correspondent

No official correspondent registered.

US Agent Details

Franz Menean Business: MEDAGENT Inc. Email: mail@medagent-usa.com Phone: (603) 5702039

Related Public Records

Same Entity

SURGICAL INSTRUMENTS BELGIUM SA

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
K852723	The Huxley Instrument Corp.	FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420	1985-07-15
K873512	Arthropedics, Inc.	SERRATED GRASPING FORCEPS, RIGHT	1987-11-02
K851170	The Huxley Instrument Corp.	DISSECTING TWEEZER #283-72PCS. SS 410	1985-04-25
K821248	Conphar, Inc.	ROCHESTER PEAN FORCEPS	1982-05-28
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
Z-0034-2012	X Spine Systems Inc	1	Axle Interspinous Fusion System Torque Driver Handle, Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns 001-050, Mfr. By: Bradshaw Medical Inc., Kenosha, WI 53144 The Axle Torque Driver Handle is used to lock the set screw into the locking plate.

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3010287737	BAECHLER FEINTECH AG	Hoelstein Basel-Landschaft, CH
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003675041. Last updated year: 2026. Please use registration number 3003675041 when referencing this establishment in official correspondence.