Set Medikal

What Set Medikal does

Set Medikal San. ve Tic. A.Ş. is a privately held Turkish manufacturer of single-use sterile medical devices, founded in 1977 in Istanbul and operating from a 10,000 m² GMP-compliant facility (4,000 m² indoor, 6,000 m² outdoor). It is positioned as Turkey's first and largest single-use sterile syringe manufacturer and claims a place among the world's top five syringe producers, with the second-largest syringe factory in Europe by capacity. The company manufactures a catalog of more than 450 SKUs spanning syringes (2-piece, 3-piece, Luer Lock, catheter, perfusion, vaccine, insulin, tuberculin, dental, gel, blood gas, veterinary, ENFit enteral, and power-driven pump variants), hypodermic and safety needles, insulin pen needles, infusion sets, IV cannulas, extension lines, and aspiration catheters.

Core technology centers on automated, camera-based 100% in-line process control with no human contact in production, medical-grade plastics and silicone-coated stainless-steel needles, and capabilities such as low-dead-space vaccine syringes and amber light-blocking syringes (UV/visible blocking to 550 nm). Quality and regulatory certifications include ISO 9001, ISO 13485, GMP, EU MDD 93/42/EEC compliance, FDA 510(k) clearance (the first granted to a Turkish syringe manufacturer, in 2020), and Japan Ministry of Health certification.

The business model is B2B hardware sales: manufactured devices are sold through a domestic Turkish dealer/distributor network and exported to 45+ countries, with long-term contracts with European and US buyers. Reported annual revenue is approximately $20 million, of which roughly $6 million is exports, against a workforce of 150–160 employees. Customer segments are healthcare providers (hospitals, clinics), government health programs (notably COVID-19 vaccination procurement), and veterinary practices; the company generates leads and maintains relationships through a heavy trade-fair presence (Medica, Arab Health, Expomed, WHX, Pharmapack, FIME, Hospitalar) supplemented by media appearances on Bloomberg HT and APara TV.

Name

Set Medikal

Legal name

Set Medikal San. ve Tic. A.Ş.

Website

https://setmedikal.com.tr

Company type

Private

Founded year

1977

Operating status

Operating

Headcount range

101–250 employees

Short description

Set Medikal is a privately held Istanbul-based manufacturer founded in 1977, producing 450+ single-use sterile syringes, needles, infusion sets, and IV cannulas in a GMP-compliant facility with 1 billion-unit annual capacity, exporting to 45+ countries under FDA 510(k), ISO, and Japan MOH certifications.

Ownership category

akta.pro rank

Product category

Disposable Medical Devices (Sterile Syringes)

NAICS

Surgical and Medical Instrument Manufacturing (339112), Surgical Appliance and Supplies Manufacturing (339113)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Insulin Pen Needles, Syringes & Infusion Sets (Consumables) (HLAHAHAE)

akta.pro secondary industries

Prefilled Syringes & Safety Syringes (HLAHAIAA), Parenteral & Injectable Packaging Components (Stoppers, Seals, Syringes, Cartridges) (IMALAIAE), Single-Use Surgical Devices & Procedure Packs (Disposable instruments, drapes, kits) (HLAHADAM)

Keywords

• Disposable medical devices
• Sterile syringes
• Hypodermic needles
• Infusion sets
• Medical device manufacturing

Headquarters

HQ city

Istanbul

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Supply Chain, Operations, Personnel, Technology or R&D, Infrastructure, Marketing or Sales

Revenue model

1. Medical Device Manufacturing: Manufacturing and selling single-use sterile syringes, hypodermic needles, insulin pen needles, infusion sets, IV cannulas, and other medical devices. Revenue generated through product sales to healthcare providers, hospitals, clinics, and government health institutions domestically and internationally.

Go-to-market motion2 records

Distribution channels2 records

Marketing channels4 records

Core offering

Set Medikal manufactures and sells single-use sterile syringes, hypodermic needles, insulin pen needles, infusion sets, IV cannulas, perfusion syringes, blood gas syringes, enteral feeding syringes (SET Enfit), aspiration catheters, and related disposable medical devices. Products are produced at a 10,000 m² GMP-compliant facility in Istanbul with an annual capacity of 1 billion syringes and sold to hospitals, clinics, healthcare providers, government health programs, and distributors in more than 30 countries.

Product overview

Set Medikal is Turkey's first and largest single-use sterile syringe manufacturer, producing a comprehensive portfolio of disposable medical devices. The core product lineup includes various syringe types (2p, 3p, Luer Lock, catheter, perfusion, vaccine, insulin, tuberculin, dental, and veterinary syringes), hypodermic needles including safety variants, insulin pen needles, infusion sets, IV cannulas, extension lines, blood gas syringes, enteral feeding syringes (SET Enfit), aspiration catheters, and gel syringes. All products are manufactured in GMP-compliant facilities with ISO 9001 and ISO 13485 certifications, with FDA 510(k) clearance enabling export to the US market. The company operates from a 10,000 m² facility in Istanbul with a production capacity of 1 billion syringes annually, exporting to over 30 countries.

Differentiator

Problem solved

Functional benefit

Products and services

• Syringes (Şırınga)

Quantifiable outcome

• 60% market share in Turkey for syringes
• +3 more outcomes

Named customers1 record

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Scale indicators10 records

Recent moves8 records

Expansion highlights4 records

Direct peers

• ICU Medical: US-based manufacturer specializing in IV therapy, infusion sets, and safe-handling medical devices. Overlaps directly with Set Medikal's infusion sets, IV cannulas, and extension lines in clinical hospital channels.
• Smiths Medical: Specializes in disposable medical devices including syringes, infusion sets, and IV cannulas — overlapping directly with Set Medikal's core product family. Comparable in customer base (hospitals, vaccination programs) though larger and more diversified across vascular access and safety devices.
• Hindustan Syringes & Medical Devices (HMD): One of the world's largest syringe manufacturers and the dominant Indian supplier of disposable syringes to UN agencies and government immunization programs. Closest direct peer by product mix and customer base (vaccine syringes, AD syringes); competes with Set Medikal in international tenders.
• Nipro Corporation: Japanese-headquartered manufacturer of syringes, needles, infusion sets, and IV cannulas with global manufacturing footprint. Direct competitor in the same disposable injection-device categories, particularly in emerging markets where Set Medikal also exports.
• Shandong Weigao Group: One of China's largest manufacturers of medical consumables including syringes, needles, and infusion sets. Competes with Set Medikal in price-sensitive emerging market tenders and represents the principal Asian cost-pressure competitor.

Broad incumbents

• Terumo Corporation: Japanese medical device manufacturer with a major syringes, needles, and infusion systems business. Comparable regulatory positioning (Japan MOH-equivalent quality standards) and overlapping product categories; competes in premium institutional segments where Set Medikal is also targeting.
• Cardinal Health: Major US medical product distributor and manufacturer with an extensive portfolio of injection and infusion supplies. Overlaps as both a potential customer (via distribution) and competitor in select institutional channels serving hospitals and vaccination programs.
• B. Braun: German medical device and pharmaceutical company with a substantial infusion, injection, and IV consumables portfolio. Competes in European institutional markets that are core export destinations for Set Medikal, particularly Germany and broader EU.
• Becton, Dickinson and Company (BD): Global medical technology leader with a dominant portfolio of syringes, needles, and injection systems. BD is the largest direct comparator in single-use syringes and IV cannulas, competing with Set Medikal across institutional and government tenders, though operating at vastly greater scale and breadth.

Emerging players

• Retractable Technologies: US-focused manufacturer specializing in safety syringes designed to prevent needlestick injuries. Comparable in the safety-needle sub-segment where Set Medikal also offers Güvenlikli İğne products, though operating primarily in North American institutional channels.

Market position

Strengths4 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/SetMedikal

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Set Medikal