The Standard

What The Standard does

The Standard Co., Ltd. (더스탠다드) is a privately held South Korean medical device manufacturer founded in 2006 and headquartered in Gunpo-si, Gyeonggi-do. The company develops, manufactures, and sells proprietary medical devices across three primary therapeutic areas: gastroenterology (endoscopic marker inks, submucosal injection agents, and biliary drainage catheters), cardiac electrophysiology (diagnostic EP catheters), and oncology (Irreversible Electroporation systems for non-thermal tumor ablation). Its flagship products include the Black Eye™ endoscopic tattooing ink (CE-marked 2013, FDA-registered 2018, designated as a Korean "World-Class Product" in 2017), the SMART™ EP catheter (Korea's first domestically developed arrhythmia diagnostic catheter), and the EPO-IRE® system (Korea's first and the world's second IRE cancer treatment platform, with Korean NET certification and initial deployments at Samsung Seoul Hospital and Seoul St. Mary's Hospital). The company also produces prefilled syringes (NAMI) and operates an FDA-registered Contract Development & Manufacturing (CDM) business providing design, development, validation, and mass production services to medical device OEMs.

The business model combines direct medical device sales — enterprise field sales to Korean hospitals plus regional distributor networks in Europe and Asia — with CDM services revenue. Demand generation is event-driven, with active participation in major international congresses (ESGE Days, UEGW, APDW, Medical Fair India) as the primary channel. The company holds a comprehensive regulatory portfolio (ISO 13485, KGMP, CE, FDA, MDSAP, MDR, KOLAS, GLP) and operates an in-house KOLAS-accredited testing laboratory that was designated in 2012 and spun off as The Standard Lab (주식회사 스탠다드랩) in 2024, with GLP accreditation for cytotoxicity testing added in 2025.

The customer base is concentrated in Korean tertiary hospitals, with EP catheters deployed across more than 40 sites including Samsung Seoul Hospital, Seoul St. Mary's Hospital, and Sinchon Severance Hospital. The firm began expanding its international footprint in 2025-2026 through distributor development in Europe (Italy), South Asia (India), and Southeast Asia (Singapore, Philippines, Vietnam, Thailand). Leadership consists of founder-CEO Kim Seong-nam (김성남), who was appointed inaugural chairman of the Korean Medical Devices Regulatory Reform Council in July 2025.

Name

The Standard

Legal name

THE STANDARD CO., LTD.

Website

https://thestandard.co.kr

Company type

Private

Founded year

2006

Operating status

Operating

Headcount range

51–100 employees

Short description

The Standard Co., Ltd. is a South Korean medical device manufacturer founded in 2006, producing endoscopic marking inks, electrophysiology catheters, IRE cancer treatment systems, prefilled syringes, and contract manufacturing services for hospitals and medical device OEMs domestically and via international distributors in Europe and Asia.

Ownership category

akta.pro rank

Product category

Medical Devices

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Surgical and Medical Instrument Manufacturing (339112), Navigational, Measuring, Electromedical, and Control Instruments Manufacturing (3345)

SIC

Surgical & Medical Instruments & Apparatus (3841), Electromedical & Electrotherapeutic Apparatus (3845)

akta.pro primary industry

Endoscopy Systems & Accessories (Scopes, Cameras, Light Sources, Insufflation) (HLAHADAB)

akta.pro secondary industries

Endoscopic Therapeutic & Access Devices (Trocars, dilators, biopsy/ablation tools) (HLAHADAN), Sterile Fill-Finish & Aseptic Manufacturing CDMO (HLAGABAH), Manufacturing Quality Assurance & GMP Compliance (batch release, deviation/CAPA, tech transfer QA) (HLAGAKAJ)

Keywords

• Endoscopic medical devices
• Electrophysiology catheters
• Irreversible electroporation cancer ablation
• Contract medical device manufacturing
• Biliary drainage catheters

Headquarters

HQ city

Gunpo

HQ country

South Korea

HQ region

Asia

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Medical Device Manufacturing & Sales: The Standard manufactures and sells proprietary medical devices including endoscopic marker inks (Black Eye), submucosal injection agents (Blue Eye), electrophysiology catheters, ENBD catheters, IRE cancer treatment systems, and prefilled syringes. Revenue is generated through direct hospital sales and distributor channels in domestic Korean and international markets.
2. CDM (Contract Development & Manufacturing): One-stop CDM services covering medical device design, development, trial production, regulatory testing, and mass production. Services include cleaning validation, packaging validation, sterilization validation, transport validation, EO gas residual testing, shelf-life setting tests, and GLP biocompatibility testing. Targets startups with limited development experience and large OEMs seeking efficient production expansion.

Go-to-market motion3 records

Distribution channels4 records

Marketing channels5 records

Core offering

The Standard manufactures and sells proprietary medical devices for hospitals—endoscopic marker ink (Black Eye™), submucosal injection agent (Blue Eye™), arrhythmia diagnostic catheters (SMART™ EP), biliary drainage catheters (SMART™ ENBD), Irreversible Electroporation cancer ablation systems (EPO-IRE®), and prefilled syringes (NAMI™). The company additionally operates a CDM (Contract Development & Manufacturing) business offering one-stop design, validation, regulatory testing, and mass-production services to medical-device startups and OEM partners.

Differentiator

Problem solved

Functional benefit

Products and services

• Black Eye™ Endoscopic Marker Ink Pre-filled sterile carbon-particle suspension syringe for endoscopic tattooing of colonic lesions during GI endoscopy; leaves a non-migrating dark mark to support follow-up review. Connects directly to luer-lock injection needles, preventing air exposure and cross-contamination. For gastroenterologists performing lesion marking.
• Blue Eye™ Submucosal Injection Agent Submucosal injection agent used during endoscopic procedures (e.g., EMR/ESD) to lift lesions for safer resection. Received FDA clearance in 2022. For gastroenterology endoscopy departments.
• SMART™ Electrophysiology (EP) Catheter Korea's first domestically developed arrhythmia diagnostic catheter, with optimized electrode design (1.2mm and 2.0mm electrode rings), multi-curve options, and high-resolution signal processing. Validated in 40+ Korean tertiary hospitals. For cardiology electrophysiology labs.
• SMART™ Endoscopic Nasal Biliary Drainage (ENBD) Catheter Endoscopic Nasal Biliary Drainage Catheter for diagnosis and treatment of malignant biliary obstruction, with J-Loop transfer tube removal, pigtail and alpha-curve design minimizing movement, soft shaft for patient comfort, and 9 drainage holes. For endoscopy and HPB teams.
• EPO-IRE® Irreversible Electroporation System Non-thermal ablation technology that selectively destroys cancer cells using strong electrical pulses while preserving blood vessels, nerves, and surrounding healthy tissue. Uses ECG-synchronized pulses with adjustable Solo, Dual, Triple, and Quad probes for targeted tumor ablation in pancreas, liver, kidney, and prostate cancers. For oncology, HPB surgery, and interventional radiology.
• NAMI™ Prefilled Syringe Prefilled syringe manufactured under ISO 11040-6:2019 and ISO 13485:2016 including ISO Class 8 cleanroom. Cyclic Olefin Copolymer (COC) barrel with luer lock cone per ISO 80369-7:2016, sterilized with Ethylene Oxide per ISO 11135:2014, preservative-free, DEHP-free, latex-free, and non-pyrogenic. For hospitals, OEMs, and sterile injectable applications.
• CDM (Contract Development & Manufacturing) Services One-stop CDM services for medical devices covering design, development, trial production, regulatory testing, and mass production. Includes cleaning validation, packaging validation, sterilization validation, transport validation, EO gas residual testing, shelf-life testing, and GLP biocompatibility testing. Targets medical-device startups with limited development experience and large OEMs seeking efficient production expansion.

Quantifiable outcome

• Black Eye achieves non-migrating dark tattoo marking for precise GI lesion marking, validated by peer-reviewed clinical study (Milone et al., 2019, Techniques in Coloproctology).
• +3 more outcomes

Named customers4 records

Segments3 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Seven partnerships are on record, tiered core and minor.

• Korean Medical Devices Association (한국의료기기협동조합)coreStrategic or Co-development Partner · 31 July 2025The Standard's CEO Kim Seong-nam was appointed as the founding chairman of the 'Korean Medical Devices Regulatory Innovation Council' launched by the Korean Medical Devices Association. The council operates with industry experts driving regulatory improvement tasks and directly communicating with government. Structured into 6 subcommittees including advanced, in vitro diagnostics, cardiovascular imaging, orthopedic rehabilitation, oral/digestive, and digital medical devices.
• Severance Hospital (Sinchon Severance Hospital)coreStrategic or Co-development PartnerClinical partnership for IRE (Irreversible Electroporation) cancer treatment. Sinchon Severance Hospital started IRE clinical application for pancreatic cancer (LAPC) patients in 2023, expanded to liver cancer (HCC) patients in 2024. The hospital serves as a key clinical site analyzing IRE procedure safety and efficacy outcomes.
• Samsung Seoul HospitalcoreStrategic or Co-development PartnerClinical partnership for IRE equipment delivery and clinical application for liver cancer (HCC) patients. IRE equipment delivered to Samsung Seoul Hospital as part of ongoing cancer treatment collaboration.
• Seoul St. Mary's HospitalcoreStrategic or Co-development PartnerClinical partnership for IRE equipment delivery and clinical application. IRE equipment delivered to Seoul St. Mary's Hospital for cancer treatment procedures.
• CDM Business Partner CompaniesminorStrategic or Co-development PartnerThe CDM business page displays approximately 12 partner/client logos representing companies that utilize The Standard's contract development and manufacturing services. Specific partner names were not individually identified in the source material.
• European Regional DistributorsminorChannel Partner/ Reseller/ DistributorRegional distributors across European countries engaged through international exhibitions including ESGE Days 2026 (Milan, Italy). Discussions with existing European distributors and new business partners focused on collaboration opportunities and business expansion in the European market.
• Asian Regional DistributorsminorChannel Partner/ Reseller/ DistributorRegional distributors across Asian countries engaged through exhibitions including Medical Fair India 2026 and APDW 2025 (Singapore). Active discussions with new potential distributors from Singapore, Philippines, Vietnam, and Thailand for market expansion in the Asian region.

Scale indicators5 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• AngioDynamics: U.S. medical device manufacturer whose NanoKnife system is the global pioneer and incumbent in Irreversible Electroporation tumor ablation. Directly comparable as the only other commercially available IRE platform competing with EPO-IRE® in pancreatic, liver, prostate and kidney cancers.
• MicroPort Scientific Corporation: Shanghai-headquartered medical device company with a substantial cardiac electrophysiology catheter portfolio and broad Asian distribution. Comparable as a direct Asia-based EP catheter peer operating in similar hospital channels.
• CONMED: U.S. medical device manufacturer with general surgery and electrophysiology product lines. Comparable as a mid-sized diversified medical device peer with overlapping surgical/EP catheter offerings and similar channel dynamics to hospitals.
• Cosmo Pharmaceuticals: Ireland/Switzerland-based specialty pharmaceutical and medical device company with GI endoscopy products including submucosal injection agents. Directly comparable as a competitor in the endoscopic injection/marker product category where Blue Eye competes.

Broad incumbents

• Biosense Webster (Johnson & Johnson): Global market leader in cardiac electrophysiology diagnostic and ablation catheters, part of J&J MedTech. Competes head-to-head with SMART™ EP Catheter in arrhythmia mapping across Korean tertiary hospitals and worldwide EP labs.
• Boston Scientific: Global medical device incumbent with significant electrophysiology and endoscopy franchises. Comparable as a broad incumbent whose EP catheter line directly contests SMART™ and whose endoscopy business overlaps with The Standard's GI marker ink and injection products.
• Abbott: Diversified medical device major with a leading electrophysiology portfolio (acquired St. Jude Medical). Comparable broad incumbent competing in cardiac EP catheters alongside SMART™ and across adjacent cardiology diagnostics.

Others

• STERIS: Global infection prevention and endoscopy products/services provider with adjacent GI endoscopy consumables. Comparable as an enabling/adjacent participant in the endoscopy workflow where The Standard's marker inks and injection agents are used.

Emerging players

• Creo Medical: U.K.-based emerging medical device company developing advanced endoscopic therapeutic and ablation technologies. Comparable as a smaller specialist focused on GI endoscopy therapeutic devices intersecting with The Standard's endoscopy and IRE-adjacent portfolios.
• Pulse Biosciences: U.S. clinical-stage company developing Nano-Pulse Stimulation, a non-thermal electrical ablation technology conceptually adjacent to IRE. Comparable as an emerging player in the same electroporation-based cancer treatment category.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks7 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/@thestandardco
• LinkedInlinkedin.com/company/black-eye-endoscopic-marker

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 The Standard