S. P. Enterprise - Medical Disposables, Surgical Instruments & Medical Equipment Manufacturer Kolkata India

About S. P. Enterprise

Committed to Surgical Excellence, Quality & Precision

S. P. Enterprise, Kolkata, India is an accomplished medical device manufacturer specializing in precision-engineered surgical disposables and clinical equipment designed for uncompromising clinical accuracy.

As an AN ISO 9001 & ISO 13485 Certified Company, we prioritize the quality, sterility, and tactile consistency of our latex-free surgical items. Every stage of manufacturing undergoes stringent optical inspection, dimensional gauging, and sterile seal validation.

In addition, S. P. Enterprise provides bespoke OEM contract manufacturing, custom blade diameter fabrication (up to 25mm), and private-label packaging tailored precisely to international export standards.

ISO 13485:2016 CertifiedFDA Registered FacilityCE Conformity
Accreditation & Compliance

Internationally Certified Quality Standards

All manufacturing operations at S. P. Enterprise adhere strictly to audited global quality protocols. Inspect our official certifications below.

Medical Device Standard

ISO 13485:2016

Medical Devices Quality Management System

Certified standard for design, manufacture, sterile packaging, and distribution of medical surgical disposables.

International Quality

ISO 9001:2015

Quality Management Systems Standard

International benchmark for continuous manufacturing quality, strict batch testing, and organizational reliability.

Export Compliance

CE Registration & Compliance

European Conformity & Global Regulatory Alignment

Certificate of registration affirming compliance with international regulatory health and safety benchmarks.