SteryLab

What SteryLab does

SteryLab (STERYLAB S.r.l.) is an Italian medical device manufacturer founded in 1974 and headquartered in Rho (Milan), Italy, specializing in precision medical needles and devices for diagnostic and interventional procedures. The company operates a 3,000 sq.mt. ISO 9001- and ISO 13485-certified manufacturing facility that includes one of Europe's largest ISO Class 5 CleanRooms dedicated to medical needle assembly. Its portfolio spans approximately 40 products across interventional radiology, clinical oncology/hematology, mammography, gynaecology, infection control, MRI-guided procedures, antenatal diagnostics, and vertebroplasty, including bone-marrow biopsy needles (BEST-LISAS, PARAGON), echogenic Chiba and TruCut biopsy needles, breast localization devices, vascular access needles, and laparoscopic accessories.

Core technical differentiation is built on three proprietary technology pillars: ECHONOX®, a patented echogenic stainless steel alloy enabling full-length needle visibility under ultrasound and MRI; NOLOSE® / SAFE-LOCK, a patented core retention system preventing lost specimen cores in bone-marrow biopsy; and IFR® Cell Rescue, a mechanical cell-recovery feature for cytology sampling. The company also operates an NFC-based anticounterfeiting mobile app for product authentication. Products are designed for compatibility with major capital equipment platforms, including MAGNUM (BD/C.R. Bard), PRO-MAG (Argon), and Esaote-Hitachi ultrasound probes.

SteryLab monetizes exclusively through hardware sales of sterile, single-patient-use medical devices, with pricing not publicly disclosed and product information gated behind verified healthcare-professional access. Go-to-market is executed entirely through a global network of exclusive and non-exclusive distributors, supported by training, logistics, and marketing enablement. Distribution is supplemented by a wholly-owned US subsidiary (STERYLAB USA L.L.C., Franklin, Indiana) serving North America. The company is privately held with no disclosed parent, external investors, or funding rounds in the source material.

Name

SteryLab

Legal name

STERYLAB S.r.l.

Website

https://sterylab.it

Company type

Private

Founded year

1980

Operating status

Operating

Headcount range

11–50 employees

Short description

SteryLab is a privately held Italian medical device manufacturer specializing in proprietary echogenic needles and biopsy devices for interventional radiology, oncology, mammography, and gynaecology, sold globally through a distributor network from its ISO-certified Rho (Milan) facility.

Ownership category

akta.pro rank

Product category

Medical Devices

NAICS

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

SIC

Surgical & Medical Instruments & Apparatus (3841), Orthopedic, Prosthetic & Surgical Appliances & Supplies (3842), Wholesale-Medical, Dental & Hospital Equipment & Supplies (5047)

akta.pro primary industry

Medical & Life Sciences Injection Molding (Devices, Diagnostics, Cleanroom) (IMANAFAC)

akta.pro secondary industry

Medical Device Packaging (Trays, Clamshells, Kits) (IMALAIAD)

Keywords

• Medical needles
• Biopsy devices
• Interventional radiology
• Bone marrow biopsy
• Medical device manufacturing

Headquarters

HQ city

Rho

HQ country

Italy

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Medical Devices and Needles Sales: SteryLab designs, manufactures, and sells medical needles and devices across multiple clinical specialties including interventional radiology, mammography, clinical oncology, gynecology, and infection control. Products are sold as sterile, single-patient use devices to healthcare providers worldwide through distributor networks.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels2 records

Core offering

SteryLab designs, manufactures, and sells sterile single-patient use medical needles and devices for diagnostic and interventional procedures. The portfolio covers interventional radiology (biopsy needles), clinical oncology/hematology (bone marrow biopsy and aspiration needles), mammography (breast biopsy and localization), gynaecology, MRI-guided procedures, and infection control, featuring proprietary technologies such as ECHONOX® echogenic stainless steel alloy and NOLOSE® core retention systems. All manufacturing occurs in an ISO 5 CleanRoom in Rho (Milan), Italy, under ISO 9001 and ISO 13485 certifications.

Product overview

STERYLAB is an Italian medical device manufacturer specializing in precision medical needles and devices for over 45 years. The company operates internal CleanRoom facilities (ISO 5 class) in Rho, Milan and maintains ISO 9001 and ISO 13485 certifications. The product portfolio includes 40+ medical devices organized across 12 categories: Accessories (3R-S, ESA-ESN-CGR, PAC, PAC-UF), Antenatal Diagnostic (VCS), Clinical Oncology (BEN, BEST-LISAS, BEST-LISAS DUAL, BTT, MIELO-CAN, PARAGON, PORT-JECT), Gynaecology (ISTEROMETRO, KARMAN, VABRA), Infection Control (MULTIMAT), Interventional Radiology (ATA-CUT, BIO-CUT, COLT, COMPLETE-CHIBA, ECOCHIBA, FAST-CUT, FAST-CUT B, FAST-CUT C, FAST-GUN, FULL-OPTY, HEPA-CUT, MAMMOREP, MAMMOREP LOOP, MULTICORE, PIA, SGL, SPRING-CUT, VERTOPLAST, X-SCREEN), Mammography (CARBO-REP, CYTOMAT, MAMMOFLUSH), MRI Devices (MR-CLEAR), and Vertebroplastic (VERTOPLAST). Products feature proprietary technologies including ECHONOX echogenic metal alloy for ultrasound visibility and NOLOSE/SAFE-LOCK core retention systems. The company also offers an NFC-based anticounterfeiting verification app.

Differentiator

Problem solved

Functional benefit

Brands

• Sterylab Anticounterfeiting NFC App: Mobile application for verifying authenticity of Sterylab medical devices through NFC technology.

Products and services

• 3R-S

Quantifiable outcome

• 100% success in retrieval of intact specimen (PARAGON bone-marrow biopsy)
• +2 more outcomes

Segments5 records

Ideal customer profiles5 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration4 records

Feature6 records

Partnerships

One partnership is on record.

• Global Medical Device DistributorscoreChannel Partner/ Reseller/ DistributorSTERYLAB has established exclusive and non-exclusive partnership arrangements with distributors worldwide. Exclusive distributors receive logistical support, training on medical environment and pathologies, product training, and marketing/promotional support.

Scale indicators3 records

Recent moves1 record

Expansion highlights5 records

Direct peers

• Integra LifeSciences: Specialty medical device manufacturer with a dedicated interventional radiology and biopsy portfolio overlapping SteryLab's TruCut-type and Chiba-type needle offerings, particularly in oncology and neurosurgery.
• Cook Medical: Global manufacturer of biopsy needles, interventional radiology devices, and specialty medical instruments with deep overlap across soft tissue biopsy, breast localization, and vertebroplasty product categories where SteryLab competes.
• Hologic: Direct peer in breast biopsy and mammography — competes with SteryLab's MAMMOREP, MAMMOREP LOOP, CARBO-REP, CYTOMAT, and MAMMOFLUSH breast localization and cytology product lines in the diagnostic mammography segment.
• Merit Medical Systems: Direct peer offering soft tissue biopsy needles, bone biopsy systems, and interventional radiology consumables, competing head-to-head with SteryLab's BIO-CUT, FAST-CUT, and related product lines globally.
• Argon Medical Devices (now part of ICU Medical): Direct peer in biopsy needles and interventional radiology devices; SteryLab's FAST-CUT C needle is explicitly designed to integrate with Argon's PRO-MAG biopsy gun, evidencing direct product overlap in soft tissue and bone biopsy.

Broad incumbents

• Stryker: Broad incumbent with significant interventional spine and orthopedic surgical device presence, including vertebroplasty/kyphoplasty systems directly comparable to SteryLab's VERTOPLAST cement delivery system.
• Boston Scientific: Broad incumbent in interventional radiology and oncology devices with biopsy, ablation, and vertebroplasty product lines overlapping SteryLab's interventional radiology and vertebroplasty portfolio at larger scale.
• Cardinal Health: Major medical device distributor and manufacturer with overlapping distribution channels for hospital and interventional radiology consumables, and manufacturer of surgical and biopsy instruments comparable to SteryLab's portfolio.
• Becton Dickinson (BD): Global medical device incumbent that absorbed C.R. Bard and offers MAGNUM biopsy guns referenced directly in SteryLab product integrations; BD's scale, regulatory, and distribution resources dwarf SteryLab's in every overlapping procedure category.

Regional players

• Möller Medical: German specialty manufacturer of biopsy needles, vertebroplasty systems, and interventional radiology devices with comparable product breadth to SteryLab but primary geographic focus on German-speaking European markets.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/sterylab

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Subsidiaries1 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 SteryLab