About SEVA Devices

A different kind of disposables company.

SEVA Devices supplies OEM-grade contrast injector syringes and disposables direct to radiology departments, manufactured to the same standards as the OEM products your department has relied on for decades. No bundling, no proprietary lock-in, no contracting friction.

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Direct

Sold direct. No distributor markup. No contrast bundling.

OEM

Same manufacturing standards as the products you already trust

U.S.

Operations based in the U.S. European expansion planned

SEVA Positioning Statement

SEVA Devices supplies the contrast injector syringes and disposables your radiology department relies on, manufactured to the same standards as OEM products, produced by the same global contract manufacturer that supplies a major European manufacturer of injector consumables and disposables, and sold direct to imaging operations without bundling, without proprietary lock-ins, and without the contracting friction that defines OEM relationships. SEVA exists so that Radiology Administrators can stop thinking about contrast disposables and get back to running their departments.

The Company

Built to solve a specific problem.

Radiology departments were paying OEM prices for contrast disposables they could not leave, on contracts they could not negotiate, bundled with contrast media they did not need to bundle. SEVA was built to change that.

SEVA Devices was co-founded by Denny Durmis and Rakesh Amin to address a structural inefficiency in the U.S. radiology disposables market. The major OEMs, Bayer, Bracco, Guerbet, GE, and Nemoto, have progressively driven customers toward proprietary platforms and bundled contracts that tie injector disposables to contrast media purchases. The clinical performance of the disposables themselves is largely equivalent across generations. The commercial terms are not.

The phrase "alternative source" is retired from all SEVA materials. SEVA is not in that category.

SEVA's structural advantage is manufacturing pedigree. SEVA products are produced by the same global contract manufacturer that supplies a major European manufacturer of injector consumables and disposables. This is materially different from competitors in the so-called alternative source category, which compete primarily on price without comparable manufacturer credentials. SEVA is not in that category and is not marketed as such.

The business sells direct. Contracts with imaging centers, hospitals, and IDNs are written without distributor layers, without contrast media requirements, and without the proprietary lock-ins that follow every Bayer, Bracco, or Guerbet capital upgrade. GPO access is available through HPG, with Premier in progress. All customer service stays SEVA-branded regardless of the contracting channel.

SEVA currently operates in the U.S. market. European expansion is planned, with timing to be confirmed. The site and operational infrastructure are built to support international customers without structural rework.

SEVA.

Sanskrit · सेवा

Selfless service.

The name is drawn from the Sanskrit word seva, meaning selfless service, with a particular emphasis on service directed toward others rather than oneself. In its oldest sense it describes care rendered without expectation of return.

That principle shapes how SEVA operates. Radiology departments should not have to negotiate, worry, or think about their contrast disposables. The supply should simply work. The pricing should be fair. The service should be invisible in the best possible sense. That is what selfless service looks like in a radiology department.

Why SEVA

Three things no other non-OEM supplier can say.

Hundreds of companies sell contrast injector disposables. Very few can make all three of these claims simultaneously.

01 · Manufacturing

OEM-grade pedigree.

Manufactured by the same global contract manufacturer that supplies a major European manufacturer of injector consumables and disposables. Same GMPs, same particulate controls, same regulatory framework as the OEM products your department already uses.

02 · Commercial

No bundling. No lock-in.

SEVA does not sell contrast media and does not bundle disposables with any other product. Direct contracts. Transparent pricing. GPO access for members. No proprietary platform requirement. Your existing contrast relationships are unaffected.

03 · Regulatory

Every credential is verifiable.

FDA 510(k) cleared. ISO 13485:2016 certified. EU MDR compliant. CE marked. Every credential has a document behind it. K-numbers, certificates, declarations of conformity, and product specifications are available to qualified buyers and VAC reviewers on request.

Manufacturing Pedigree

The supply chain behind the syringe.

Manufacturing provenance is SEVA's strongest single credential. It is the fact that separates SEVA from every other non-OEM supplier in the U.S. market, and it is stated plainly rather than buried in fine print.

The Provenance Claim

Same manufacturer. Same standards.

SEVA products are manufactured by the same global contract manufacturer that supplies a major European manufacturer of injector consumables and disposables. This is the public statement SEVA makes on its homepage and product pages. It is accurate, substantiated, and verifiable by qualified supply chain reviewers.

What This Means in Practice

Same GMPs. Same particulate controls. Same framework.

The manufacturing controls that define OEM-grade quality are codified in regulations and standards, not proprietary to any single company. SEVA's products are manufactured to 21 CFR Part 820, EU MDR GMP requirements, ISO 13485:2016, ISO 10993 biocompatibility, ISO 11135 sterilization validation, and the same particulate specifications applied to OEM contrast injector syringes.

How It Differs from Competitors

Not in the alternative source category.

Competitors in the so-called alternative source or second source category, including suppliers based in Shenzhen, Wuxi, and other manufacturing centers, compete primarily on price. SEVA does not. Manufacturing pedigree shared with a major European OEM supplier is a structural difference, not a marketing claim, and it determines where SEVA competes and how SEVA prices.

Leadership

Founded by people who know the market.

SEVA was founded by two people with direct experience in the radiology disposables market, the OEM commercial model, and the global medical device supply chain. The company's positioning comes from that experience.

Denny Durmis

Co-Founder

Denny brings over 28 years of experience in global market development, commercial strategy, and leadership in the medical and healthcare sectors. He previously held SVP-level roles at Bayer Radiology, covering EMEA and the Americas, and at Medrad, where he also led the integration of Medrad into Bayer following its acquisition. He holds an MBA from Carnegie Mellon and a BS in Electrical Engineering from the University of Pittsburgh. He has served as an active Board Member with MITA, AdvaMed, and Life's Work of Western PA. That background, inside the OEM commercial model at its most senior levels, shapes SEVA's positioning, product strategy, and go-to-market approach.

Rakesh Amin

Co-Founder

Rakesh leads SEVA's operational and technical execution, including the global manufacturing relationship, regulatory infrastructure, and technology platform. He manages SEVA's offshore execution team and holds final approval on technical implementation across the business. His background spans global medical device supply chain, contract manufacturing relationships, and the regulatory frameworks that govern Class II medical devices in the U.S. and EU markets. The manufacturing pedigree that defines SEVA's positioning is built on the supply chain infrastructure Rakesh has established and continues to manage.

Commercial Team

The people who answer the phone.

SEVA's commercial team handles every customer inquiry directly. No call center, no automated routing. Kim, Kelley, and Janet manage the relationship from first contact through ongoing supply.

Kim Carson

Commercial Lead

First point of contact for all new inquiries. Triages opportunities, coordinates pricing, and manages the customer relationship through contract execution and beyond.

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Kelley Nestor

Account Manager

Handles sample coordination, VAC support documentation, and ongoing account management. Primary contact for hospital and IDN accounts through the evaluation and contracting process.

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Janet Brown

Account Manager

Supports customer evaluation processes, technologist questions, and post-contract onboarding. Primary contact for imaging center accounts and outpatient evaluations.

Contact Janet →

Market Context

A $500M market. With a clear opening.

The U.S. radiology contrast injector consumables market is approximately $500 million annually, growing at roughly 5% per year. Approximately half the market is locked into OEM-proprietary platforms with substantial patent life remaining. SEVA's currently addressable segment is approximately $250 million, expanding as the Bayer EOL events push equipment off the forced-upgrade path and into SEVA's lane.

SEVA holds a position no other non-OEM supplier in the U.S. market holds: manufacturing pedigree shared with a major European medical device manufacturer, sold direct, into a market heading toward a once-in-a-decade end-of-life event between now and 2028. The website exists to make that position visible to the Radiology Administrators who are about to need it.

$500M

U.S. radiology contrast disposables market, growing at 5% annually

$250M

Currently addressable by SEVA across supported platforms

20+

Injector models supported across CT, MR, and angiography

Bayer EOL platforms SEVA continues to supply past OEM cutoff

Get In Touch

Ready when you are.

Request pricing, samples, or a VAC evaluation kit. SEVA's commercial team responds within one business day. No sales pitch. Just answers and a quote built around your volume.

Request Information Or call us directly

Phone

+1 (878) 808-9500

sales@sevadevices.com

Fax

+1 (412) 346-6511