FDA Registration
Active
🇵🇰 Pakistan
QUALITY CONCEPT (PVT) LTD.
Reg #: 3002090132
·
FEI: 3002090132
·
Expires 2026
Products
46
Proprietary Names
49
Establishment Types
1
Classifications
46
Registration Details
- Registration Name
- QUALITY CONCEPT (PVT) LTD.
- Registration Number
- 3002090132
- FEI Number
- 3002090132
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 15-A /01 SMALL INDUSTRIAL ESTATE
- City
- SIALKOT Punjab
- Country
- PK
Regulatory Submissions
- 510(k) Number
- K043533
Owner / Operator
- Firm Name
- QUALITY CONCEPT (PVT) LTD.
- Operator Number
- 9051639
- Address
- 15-A /01 SMALL INDUSTRIAL ESTATE, --
- City
- SIALKOT
- State
- PK-NOTA
- Postal Code
- --
- Country
- PK
US Agent
- Business Name
- SURGICAL DESIGN, INC
- Contact Name
- KHALIL Jebraan
- Address
- 7351 LOCKPORT PL STE D
- City
- LORTON
- State
- VA
- ZIP
- 22079
- Country
- US
- [email protected]
- Phone
- 703 5410196
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Rongeur | HTX | Class 1 | Orthopedic | No | 2020-07-02 |
| Scaler, Periodontic | EMN | Class 1 | Dental | No | 2019-08-01 |
| Knife, Surgical | EMF | Class 1 | General, Plastic Surgery | No | 2020-07-02 |
| Pliers, Surgical | HTC | Class 1 | General, Plastic Surgery | No | 2020-07-02 |
| Trephine, Manual, Ophthalmic | HRH | Class 1 | Ophthalmic | No | 2025-11-25 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2020-07-02 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2004-03-15 |
| Forceps, Ent | KAE | Class 1 | Ear, Nose, Throat | No | 2016-06-22 |
| Speculum, Ent | EPY | Class 1 | General, Plastic Surgery | No | 2025-11-25 |
| Dilator, Tracheal | KCG | Class 1 | Ear, Nose, Throat | No | 2004-03-15 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2002-06-12 |
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 2004-03-15 |
| Clamp, Circumcision | HFX | Class 2 | Obstetrics/Gynecology | No | 2009-06-17 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2008-01-24 |
| Elevator, Surgical, Dental | EMJ | Class 1 | Dental | No | 2016-08-31 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2004-03-15 |
| Fork, Tuning | GWX | Class 1 | Neurology | No | 2007-02-01 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 2011-11-27 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2004-03-15 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2004-03-15 |
| Remover, Crown | EIS | Class 1 | Dental | No | 2020-07-02 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2020-07-02 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2004-03-15 |
| Clamp, Eyelid, Ophthalmic | HOD | Class 1 | Ophthalmic | No | 2025-11-25 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2020-07-02 |
| Speculum, Vaginal, Metal | HDF | Class 1 | Obstetrics/Gynecology | No | 2004-03-15 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 2004-03-15 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2004-03-15 |
| Curette, Ear | JYG | Class 1 | Ear, Nose, Throat | No | 2007-01-18 |
| Handle, Instrument, Dental | EJB | Class 1 | Dental | No | 2020-07-02 |
| Gouge, Surgical, General & Plastic Surgery | GDH | Class 1 | General, Plastic Surgery | No | 2020-07-02 |
| Holder, Needle, Gastroenterologic | FHQ | Class 1 | Gastroenterology, Urology | No | 2011-07-06 |
| Sound, Uterine | HHM | Class 1 | Obstetrics/Gynecology | No | 2012-03-26 |
| Syringe, Ent | KCP | Class 1 | Ear, Nose, Throat | No | 2016-03-31 |
| Spatula, Surgical, General & Plastic Surgery | GAF | Class 1 | General, Plastic Surgery | No | 2004-03-15 |
| Dispenser, Liquid Medication | KYX | Class 1 | General Hospital | No | 2007-02-01 |
| Retractor, All Types | EIG | Class 1 | Dental | No | 2025-11-25 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2017-03-08 |
| Depressor, Metal Tongue, Surgical | KBL | Class 1 | Ear, Nose, Throat | No | 2004-03-15 |
| Gag, Mouth | KBN | Class 1 | Ear, Nose, Throat | No | 2020-07-02 |
| Otoscope | ERA | Class 1 | Ear, Nose, Throat | No | 2016-08-31 |
| Probe | HXB | Class 1 | Orthopedic | No | 2002-06-12 |
| Accessories, Retractor, Dental | EIF | Class 1 | Dental | No | 2004-03-15 |
| Hemostat | HRQ | Class 1 | General, Plastic Surgery | No | 2004-03-15 |
| Articulators | EJP | Class 1 | Dental | No | 2019-07-31 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2012-03-26 |
Proprietary Names
RONGEUR
SCALER, PERIODONTIC
KNIFE, SURGICAL
PLIERS, SURGICAL
TREPHINE, MANUAL, OPHTHALMIC
MIRROR, ,MOUTH
SCISSORS (MULTIPLE)
FORCEP ENT EAR PUNCH
SPECULUM, ENT
VARIOUS TYPES OF DILATORS
VARIOUS TYPES OF HANDLES (MULTIPLE)
NAIL CUTTERS (MULTIPLE)
VARIOUS TYPES OF WIRE CUTTERS (SURG
IPLE)
VARIOUS MODEL OF CIRCUMCISION CLAMS
Various kinds of Hooks
ELEVATOR
RIGID (MULTIPLE BRANDS)
TUNING FORKS
VARIOUS KINDS OF EYE FORCEPS
FORCEPS
MULTIPLE (VARIOUS TYPES OF FORCEPS)
REMOVER, CROWN
INSTRUMENTS, DENTAL HAND
REFLEX HAMMERS (MULTIPLE)
CLAMP, EYELID, OPHTHALMIC
CURETTE
VARIOUS TYPES OF S
BLADES
SCALPEL (MULTIPLE BRANDS)
RETRACTORS (MULTIPLE BRANDS)
Various Types of Ear Curettes
HANDLE, INSTRUMENTS, DENTAL
GOUGE, SURGICAL, GENERAL & PLASTIC SURGERY
Various Types of Needle Holders
Uterine sound
SYRINGE ,ENT
Various kinds of Spatulas
MEDICINE CUPS VARIOUS SIZES
RETRACTOR, ALL TYPES
TRAY, SURGICAL, INSTRUMENT
METAL DEPRESSOR (MULTIPLE)
GAG, MOUTH
OTOSCOPE
PROBE (MULTIPLE BRANDS)
Various Types of Dental Retractors
HEMOSTAT
ARTICULATORS
Towel Clamp
Establishment Types
Manufacture Medical Device