Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9614062

FEI Number

3000183921

Entity Name

ELMED INSTRUMENTS (PVT). LTD.

City/State/Country

SIALKOT Punjab, PK

Establishment Address

RORAS RD., NOWL CHOWK, SIALKOT Punjab 51310, PK

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ELMED INSTRUMENTS (PVT). LTD. (Owner Number: 9031923)

Owner / Operator Contact Address

RORAS RD., NOWL CHOWK, --, SIALKOT, PK-PB --, PK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2016-02-02
EGN	Scissors, Surgical Tissue, Dental	Dental	Class 1	872.4565	2019-01-12
KAI	Mirror, Ent	Ear, Nose, Throat	Class 1	874.4420	2016-02-02
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2013-01-17
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2019-01-12
HTX	Rongeur	Orthopedic	Class 1	888.4540	2007-12-04
HGC	Clamp, Uterine	Obstetrics/Gynecology	Class 1	884.4520	2013-01-17
JEX	Plier, Orthodontic	Dental	Class 1	872.4565	2013-01-17
HXL	Mallet	General, Plastic Surgery	Class 1	878.4800	2016-05-03
EPY	Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	2007-12-04
GFJ	Mallet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2019-01-12
KAL	Retractor, Ent	Ear, Nose, Throat	Class 1	874.4420	2013-01-17
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	2016-02-02
HDM	Packer, Uterine	Obstetrics/Gynecology	Class 1	884.4520	2016-05-03
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2004-07-27
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2015-08-27
GFI	Osteotome, Manual	General, Plastic Surgery	Class 1	878.4800	2019-01-12
FFQ	Speculum, Rectal	Gastroenterology, Urology	Class 1	876.4730	2013-01-17
HDJ	Scissors, Umbilical	Obstetrics/Gynecology	Class 1	884.4520	2013-01-17
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	2013-01-17
HDK	Scissors, Episiotomy	Obstetrics/Gynecology	Class 1	884.4520	2013-01-17
HWO	Skid, Bone	Orthopedic	Class 1	888.4540	2007-12-04
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	1997-10-17
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2013-01-17
EMM	Chisel, Osteotome, Surgical	Dental	Class 1	872.4565	2002-04-24
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	2013-01-17
EJY	Pliers, Operative	Dental	Class 1	872.4565	2016-05-03
EJE	Frame, Rubber Dam	Dental	Class 1	872.6300	2016-06-24
FGM	Probe And Director, Gastro-Urology	Gastroenterology, Urology	Class 1	876.4730	2019-01-12
HCY	Curette, Uterine	Obstetrics/Gynecology	Class 1	884.4530	2016-02-02
GWZ	Percussor	Neurology	Class 1	882.1700	2013-01-17
LWH	Counter, Sponge, Surgical	General Hospital	Class 1	880.2740	1997-10-17
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2016-06-24
HAO	Instrument, Surgical, Non-Powered	Neurology	Class 1	882.4535	2007-12-04
HFB	Forceps, Biopsy, Gynecological	Obstetrics/Gynecology	Class 1	884.4530	2016-02-02
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	1997-10-17
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2016-06-24
HDC	Tenaculum, Uterine	Obstetrics/Gynecology	Class 2	884.4530	2012-07-26
HNW	Dilator, Lachrymal	Ophthalmic	Class 1	886.4350	2019-01-12
KAE	Forceps, Ent	Ear, Nose, Throat	Class 1	874.4420	2016-02-02
KBD	Scissors, Nasal	Ear, Nose, Throat	Class 1	874.4420	2013-01-17
HHM	Sound, Uterine	Obstetrics/Gynecology	Class 1	884.4530	2016-05-03
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	2016-06-28
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2015-08-27
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	1997-10-17
EMG	Forceps, Tooth Extractor, Surgical	Dental	Class 1	872.4565	2007-12-04
HRQ	Hemostat	General, Plastic Surgery	Class 1	878.4800	2008-06-27
HDF	Speculum, Vaginal, Metal	Obstetrics/Gynecology	Class 1	884.4520	2016-02-02
HCZ	Forceps, Surgical, Gynecological	Obstetrics/Gynecology	Class 2	884.4530	2014-04-23
EJG	Forceps, Rubber Dam Clamp	Dental	Class 1	872.6300	2016-06-24
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	1997-10-17
KBL	Depressor, Metal Tongue, Surgical	Ear, Nose, Throat	Class 1	874.4420	2007-12-04
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2013-01-17
HDL	Retractor, Vaginal	Obstetrics/Gynecology	Class 1	884.4520	2013-01-17
HXZ	Cutter, Wire	Orthopedic	Class 1	888.4540	2019-01-12
HTC	Pliers, Surgical	General, Plastic Surgery	Class 1	878.4800	2002-04-24

Official Correspondent

No official correspondent registered.

US Agent Details

Angelika Scherp Business: BSI Business Support International Email: info@bsi-fda.com Phone: (212) 3318358

Related Public Records

Same Entity

ELMED INSTRUMENTS (PVT). LTD.

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
K821275	Conphar, Inc.	MAYO SCISSOR STRAIGHT 5 1/2	1982-05-28
K834189	Imm Enterprises , Ltd.	JAKOBI SURG. INSTRUMENTS #7 44/47	1984-03-06
K932506	Rudolf Riester GmbH & Co. KG	RI-SCOPE (S)	1993-10-08
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19
K820290	The Anspach Effort, Inc.	SELF RETAINING RETRACTOR FOR HAND SURG	1982-03-05

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-04	Rultract Inc	1	Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
Z-0007-2013	Invuity, Inc.	2	BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.
Z-0020-04	Vital Concepts, Inc.	1	Huntington Instruments brand Irrigation Aspiration System with Single Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55040. Labeled as Manufactured for Huntington Instruments, Ogden Utah.
Z-0021-04	Vital Concepts, Inc.	1	Irrigation Aspiration System with Double Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55060. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan. Huntington Instruments brand labeled as Manufactured for Huntington Instruments, Ogden Utah. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ. Catalogue # 55060-10 sold in Canada and labeled as Manufactured for Jac-Cell Medic, Dorval, Quebec.

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9681161	REBSTOCK INSTRUMENTS GMBH	DUERBHEIM Baden-Wurttemberg, DE
3003431869	HILBRO INTERNATIONAL (PVT) LIMITED	SIALKOT Punjab, PK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9614062. Last updated year: 2026. Please use registration number 9614062 when referencing this establishment in official correspondence.