Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003334541

FEI Number

3003334541

Entity Name

CONCISE ENTERPRISES

City/State/Country

Sialkot Punjab, PK

Establishment Address

Muslim Pura, Main Street Kotli Behram, Sialkot Punjab 51310, PK

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Concise Enterprises (Owner Number: 10029712)

Owner / Operator Contact Address

Muslim Pura, Main Street Kotli Behram, Sialkot, PK-PB 51310, PK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Killian Nasal Speculum Cottle Nasal Speculum Beckmann Nasal Speculum Speculum with locking screw Fraenkel Nasal Speculum Hartmann Nasal Speculum Wien Nasal Speculum Aural Speculum Spoon Excavator, Spoon Excavator (Half Hollenback), N-Excavator, Spoon Excavator (Right Angle) Excavator, Operative Instruments Multiple Brands: Medline & EU Brands GAG Mouth Mirror, Dental Explorer (Probe), Scaler, Cotton Forceps Cheek and Lip Retractors, Dental Excavators Gingival Retraction Cord, Gingival Hemostatic Agents EXAMINATION AND MEASURING INSTRUMENTS (CALIPERS),Goniometer; ,MEASURING INSTRUMENTS BERTILLON,EXAMINATION AND MEASURING INSTRUMENTS (CALIPERS) RULERS AND CALIPERS CASTROVIEJO,EXAMINATION AND MEASURING INSTRUMENTS (CALIPERS), 8 cm / 31/4 Knife & Surgical Laryngoscope Fiber-Optic Laryngoscope Rigid Laryngoscope Dental Instruments, EIY, Filling, Plastic CARVER, DENTAL AMALGAM, OPERATIVE HANDLE, INSTRUMENT, DENTAL BURNISHER, OPERATIVE Valleix Uterine Sounds Sims Uterine Sounds Martin (Simpson) Uterine Sounds Collin Uterine Sounds Surgical Scissors Examination Instruments, Restorative Instruments, Periodontal Instruments, Extraction Instruments Dental Tweezers, Dental Scaler, Dental Excavator Dental Curette, Dental Forceps General surgery & plastic suction Cannulas/Needles Plain Mouth Mirror, Front Surface Mirror, Concave Mouth Mirror Disposable Mouth Mirror, Double-Sided Mouth Mirror, Rear Surface Mirror

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EPY	Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	2026-02-06
EKC	Excavator, Dental, Operative	Dental	Class 1	872.4565	2009-07-01
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2009-06-18
KBN	Gag, Mouth	Ear, Nose, Throat	Class 1	874.4420	2009-07-01
KTZ	Caliper	Orthopedic	Class 1	888.4150	2009-07-01
GFB	Head, Surgical, Hammer	General, Plastic Surgery	Class 1	878.4820	2013-01-17
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	2009-07-01
EJP	Articulators	Dental	Class 1	872.3150	2009-07-01
GDH	Gouge, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2009-07-01
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2009-07-01
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2011-02-04
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2009-07-01
EIY	Instrument, Filling, Plastic, Dental	Dental	Class 1	872.4565	2009-07-01
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2009-07-01
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2009-07-01
EKH	Carver, Dental Amalgam, Operative	Dental	Class 1	872.4565	2009-07-01
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2009-06-30
EKJ	Burnisher, Operative	Dental	Class 1	872.4565	2009-07-01
HHM	Sound, Uterine	Obstetrics/Gynecology	Class 1	884.4530	2026-02-06
EIG	Retractor, All Types	Dental	Class 1	872.4565	2009-07-01
HDF	Speculum, Vaginal, Metal	Obstetrics/Gynecology	Class 1	884.4520	2009-07-01
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	2009-07-01
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2009-06-18
GAF	Spatula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2009-07-01
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2009-07-01
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2024-05-07
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2009-07-01

Official Correspondent

Hassan Rafique

US Agent Details

Muhammad Saqib Email: concise.us@gmail.com Phone: (972) 3425977

Related Public Records

Same Entity

Concise Enterprises

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
K834189	Imm Enterprises , Ltd.	JAKOBI SURG. INSTRUMENTS #7 44/47	1984-03-06
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
K863293	Lifestream Int'L, Inc.	DISPOSABLE SUCTION CANNULA NO. 902008-000	1986-09-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0144-2024	Covidien	1	Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
Z-0168-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only
Z-0169-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only
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
3003536766	MIQRAZ SURGICAL INDUSTRIES	Sialkot Punjab, PK
1932180	Bausch & Lomb Incorporated	Manchester, MO, US
3004892425	SPARTECH INSTRUMENTS & CO.	SIALKOT, PUNJAB, PK
9680735	HERMANN MUELLER Medizintechnik GmbH	TUTTLINGEN Baden-Wurttemberg, DE
3022320321	ALIRA MEDICAL DEVICES LLC	Rancho Cucamonga, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003334541. Last updated year: 2026. Please use registration number 3003334541 when referencing this establishment in official correspondence.