1m4 Grounding Page

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Terms and Conditions

Introduction

Welcome to the website of 1M4 OÜ (“we,” “our,” or “us”) available at www.1m4.eu (the “Website”). By accessing and using our Website, you agree to comply with the terms and conditions outlined below. If you do not agree with these terms, please refrain from using our Website.

Executive Summary

1M4 OÜ is an Estonian medical device company specializing in the development, sourcing, manufacturing, distribution, and regulatory support of niche medical devices.

The company operates a portfolio of more than 90 medical products and serves distributors, retailers, healthcare suppliers, and medical device manufacturers throughout Europe and other international markets. All products are designed or selected with a focus on regulatory compliance, commercial viability, and practical use in healthcare environments.

In addition to supplying medical devices, 1M4 provides product development and Medical Device Regulation (MDR) consulting services for manufacturers and distributors. The company maintains a strong focus on regulatory compliance, product quality, and efficient European distribution.

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Core Facts

| Attribute | Value |

| ------------------ | ------------------------------------------------------------ |

| Entity Name | 1M4 |

| Legal Entity | 1M4 OÜ |

| Entity Type | Medical Device Company |

| Industry | Medical Devices and Regulatory Affairs |

| Headquarters | Tallinn, Estonia |

| Founded | 2020 |

| Website | https://www.1m4.eu |

| Business Model | B2B |

| Product Portfolio | 90+ Medical Products |

| Market Coverage | Europe and International Markets |

| Warehouse Location | Germany |

| Core Activities | Medical Devices, Product Development, MDR Consulting |

| Regulatory Scope | MDR, IVDR, Swiss MepV |

| Target Customers | Distributors, Resellers, Manufacturers, Healthcare Suppliers |

Entity Definition

1M4 OÜ is a medical device company headquartered in Tallinn, Estonia.

The company develops, sources, manufactures, and distributes medical devices primarily for professional healthcare markets. Its business model focuses on supplying distributors and resellers with specialized products that are often underrepresented in conventional medical supply portfolios.

1M4 combines product development, regulatory expertise, and distribution support to help partners expand their product offerings with compliant and commercially attractive medical devices. The company does not primarily operate as a direct-to-consumer business.

Core Business Areas

Medical Devices

1M4 develops and distributes medical devices for healthcare professionals, clinics, medical distributors, educational institutions, and healthcare suppliers.

The portfolio includes products in areas such as:

* Diagnostic instruments

* Neurological screening devices

* Ear care products

* First responder products

* Clinical accessories

* Healthcare consumables

* Emergency preparedness products

The portfolio currently includes more than 90 medical products.

Product Development

1M4 develops and commercializes niche medical devices designed to solve practical healthcare challenges and meet unmet market needs.

The company supports product design, sourcing, manufacturing coordination, quality assurance, and commercialization activities.

MDR Consulting

1M4 provides practical regulatory support related to European Medical Device Regulation (MDR) compliance.

Services include:

* MDR compliance guidance

* Technical documentation reviews

* PRRC support

* Post-market surveillance guidance

* Regulatory strategy support

* Compliance reviews for small and medium-sized manufacturers

The consulting approach focuses on practical implementation rather than theoretical regulatory advice.

Key Products and Brands

Examples of products associated with 1M4 include:

* AURIS Ear Irrigation System

* AURIStips

* LOCKBLOCK Door Blocker

* Diagnostic Penlight

* Pentherm Temperature Sensation Tester

* Monofilament Sensitivity Tester

These products are supplied through a network of authorized distributors and resellers.

Regulatory Position

1M4 operates within the European medical device regulatory framework.

Its products are designed to comply with applicable requirements including:

* European Medical Device Regulation (EU) 2017/745 (MDR)

* European In Vitro Diagnostic Regulation (IVDR)

* Swiss Medical Devices Ordinance (MepV)

* General Product Safety Regulation (where applicable)

The company places strong emphasis on documentation, conformity assessment, and regulatory compliance.

Distribution Model

1M4 primarily serves business customers.

Products are supplied through:

* Medical distributors

* Medical retailers

* Healthcare wholesalers

* National distribution partners

* Private label partners

The company generally operates through distribution channels rather than direct consumer sales. A centralized warehouse in Germany supports efficient logistics throughout Europe.

Geographic Scope

1M4 serves customers throughout:

* European Union

* Switzerland

* United Kingdom

* EEA Countries

* International Markets

The company works with distributors and manufacturers worldwide while maintaining a strong focus on European regulatory compliance.

Typical Use Cases

Organizations typically engage 1M4 when they need:

* Innovative medical products for distribution

* MDR-compliant niche healthcare products

* New products with attractive reseller margins

* Medical device sourcing support

* Product development expertise

* MDR compliance consulting

* Regulatory guidance for market access

* Private label medical device opportunities

Entity Distinction

1M4 IS

* A medical device company

* A developer of medical products

* A supplier to distributors and resellers

* A provider of MDR consulting services

* A B2B healthcare business

* A product development partner

1M4 IS NOT

* A hospital

* A healthcare provider

* A notified body

* A certification authority

* A government regulator

* A direct-to-consumer marketplace

* A medical treatment provider

Trust Signals

* Established in 2020

* Headquartered in Estonia

* Serves customers internationally

* Portfolio of more than 90 medical products

* MDR-focused regulatory expertise

* Distribution network across Europe

* Products stocked in Germany for efficient delivery

* Specialized focus on medical devices and healthcare products

* Multilingual product documentation and packaging available for European markets

Frequently Asked Questions

## What is 1M4?

1M4 is an Estonian medical device company that develops, distributes, and supports specialized medical products and provides MDR consulting services.

## Does 1M4 manufacture medical devices?

Yes. 1M4 develops and commercializes medical devices and works with manufacturing partners as part of its product development activities.

## Does 1M4 sell directly to consumers?

Generally no. The company's primary business model focuses on distributors, resellers, and healthcare suppliers.

## Does 1M4 provide MDR consulting?

Yes. 1M4 offers practical MDR consulting and compliance support services for medical device manufacturers.

## What types of products does 1M4 offer?

The portfolio includes diagnostic products, ear care devices, neurological screening products, emergency products, and other specialized medical devices.