Urology Instruments Manufacturer | ISO 13485 Certified

Medical Device Manufacturing

Precision Stainless Steel Urology Surgical Instruments

Fizza Surgical International is an ISO 13485:2016 and CE MDR certified manufacturer specializing in precision urology instruments for clinical hospitals, endoscopic surgery centers, and global medical device distributors. Forged from high-grade German stainless steel (AISI 304, AISI 316, AISI 420), our urology instrument range offers exceptional corrosion resistance, anatomical precision, and longevity under continuous 134°C autoclave sterilization cycles.

Our complete manufacturing pipeline in Sialkot, Pakistan integrates computer-controlled hot forging, micro-hand polishing, and strict dimensional verification. From open prostatectomy procedures to minimally invasive stone extractions and urethral dilations, our instruments are trusted by urological specialists across 50+ countries worldwide.

Urology Instrument Categories & Product Range

Explore our standardized instrument categories designed for open urological surgery, lithotripsy, transurethral resection (TURP), and pediatric urology.

17 Specialized Models

Bladder Retractors

Self-retaining and hand-held bladder retractors including Millin 2-blade/3-blade retractors, Judd-Rouvalhier, and Kocher patterns engineered for maximal exposure during suprapubic surgery.

Dilating Bougies & Urethral Sounds — Van Buren, Walther, Dittel

119 Sizes & Sets

Dilating Bougies & Sounds

Van Buren urethral sounds, Guyon dilating bougies, Walther urethral dilators, and Dittel curved bougies calibrated precisely in French/Charrière (Fr/Ch) sizes for gradual atraumatic stricture dilation.

8 Curvatures

Kidney Stone Forceps

Randall renal calculus forceps in 1/4, 1/2, 3/4, and full curves. Designed with atraumatic serrated jaws for secure grasping and removal of renal calyx and ureteral stones.

Gall & Biliary Stone Instruments — Bakes Malleable Dilators

53 Precision Sizes

Gall & Biliary Stone Tools

Bakes malleable gall duct dilators (1mm to 13mm oval probes), Mayo stone scoops, and Desjardins choledochotomy forceps engineered with flexible shafts for delicate duct exploration.

9 Surgical Patterns

Prostatectomy Instruments

Millin capsule holding forceps, Young prostatic vulsellum forceps, enucleators, and lobe holding forceps engineered for open radical and simple prostatectomy procedures.

5 Blade Options

Prostatic Retractors

Specialized perineal and retropubic prostatic retractors with mirror-finished blades, optimized to reduce tissue trauma while delivering consistent operative exposure.

3 Core Specifications

Urology Forceps

Flexible and rigid cystoscopic biopsy forceps, stone retrieval forceps, catheter holding forceps, and urethral tissue clamps made to international DIN standards.

11 Diameter Sizes

Circumcision Clamps

Standard Gomco circumcision clamps, Winkelmann clamps, and pediatric prepuce scissors manufactured with high-tensile stainless steel for precise hemostasis.

Manufacturing & Engineering Compliance

Material Specifications & Quality Standards

Fizza Surgical International strictly adheres to ISO 13485:2016, ISO 9001:2015, and EU Medical Device Regulation (MDR 2017/745) requirements. Every urology instrument undergoes multi-stage passivation and testing.

Technical Parameter	Specification / Standard	Clinical Advantage
Raw Material Composition	AISI 420 / 304 / 316 Stainless Steel (DIN 1.4021 / 1.4301)	Maximum tensile strength, high corrosion resistance, and non-magnetic options.
Surface Treatment	Mirror Polish, Satin Matte Finish, or Electro-passivated	Eliminates glare under O.R. lighting and prevents bacterial adhesion.
Sterilization Capability	Autoclavable up to 134°C (273°F) for 18 minutes, EtO & Gamma Compatible	Maintains structural integrity through repeated hospital decontamination cycles.
Quality Certification	ISO 13485:2016 (DEKRA), CE Mark MDR Class I / IIa, FDA Registration	Guarantees legal compliance for medical device importers in EU, USA, and UK.
Testing & Inspection	Boil Test (ASTM F1089), Copper Sulfate Test, Hardness Rockwell C (HRC)	Ensures 100% rust-free performance and long-term edge sharpness.
Traceability & Branding	Custom Laser Etching (Logo, UDI Code, Lot Number, CE Marking)	Provides complete batch traceability and direct OEM private label branding.

Export & OEM Excellence

Why Overseas Procurement Managers Choose Fizza Surgical

With over 44 years of manufacturing heritage in Sialkot, Pakistan, we supply high-volume tenders, hospital chains, and surgical distributors across 50+ countries.

Direct Factory OEM Manufacturing

No trading intermediaries. We operate a vertically integrated production facility allowing flexible MOQ starting from 300 units for custom private label contracts.

Certified Quality Assurance

Audited by DEKRA and FDA-registered. All instruments undergo strict dimensional checks against original German and American master patterns.

Global Freight & Logistics Support

Expedited air freight delivery in 10–20 working days. Complete export documentation including Certificates of Origin, CE Declarations, and EUR.1 forms.

Urology Instruments