Question 1

What types of medical devices does Needle Concept manufacture?

Accepted Answer

Needle Concept specializes in single-use hypodermic needles, focusing primarily on intradermal injectors like the U225 series and micro-injection kits such as the MESBIO kit. Their portfolio also includes the Magic Needle, which is designed for precise medical injections. These devices are tailored for applications requiring controlled, shallow penetration.

Question 2

Where is Needle Concept based?

Accepted Answer

Needle Concept is based in France. The company’s location in France aligns with EU regulatory frameworks, which govern the classification and compliance of its medical devices.

Question 3

Which regulatory registries list Needle Concept’s devices?

Accepted Answer

Needle Concept’s devices are listed in the EUDAMED database, which is the European Union’s central registry for medical devices, and the FDA UDI (Unique Device Identification) system in the United States. These listings help ensure traceability and compliance with regulatory requirements in both regions.

Question 4

How are Needle Concept’s devices classified under EU and FDA regulations?

Accepted Answer

Needle Concept’s devices are classified as Class II and Class IIa under EU and FDA regulations. This classification is based on their intended use and risk level—Class IIa devices pose a moderate risk, requiring additional controls to ensure safety and performance, while Class II devices may involve higher risks and require stricter regulatory oversight.

NEEDLE CONCEPT

What NEEDLE CONCEPT makes

Frequently asked questions

Information

Catalogue (15)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities

Device	Model / Reference	Registries	Class	Status
U225 intradermal injector	U225-EVO	EUDAMED	Class IIa	Active
U225 intradermal injector	U225	EUDAMED	Class IIa	Active
Magic Needle	MN25G50/23G	FDA UDI	Class II	Active
Magic Needle	MN25G40/23G	FDA UDI	Class II	Active
Magic Needle	MN22G57/21G	FDA UDI	Class II	Active
Magic Needle	MN27G37/26G	FDA UDI	Class II	Active
Magic Needle	MN30G27/27G	FDA UDI	Class II	Active
Magic Needle	MN27G37/26G	FDA UDI	Class II	Active
Magic Needle	MN25G40/23G	FDA UDI	Class II	Active
Magic Needle	MN22G70/21G	FDA UDI	Class II	Active
Magic Needle	INC22G70	EUDAMED	Class IIa	Active
MESBIO Micro-injection kit	MIK27G	EUDAMED	Class IIa	Active
Hypodermic Needle	INM27G04	EUDAMED	Class IIa	Active
Magic Needle	INC18G70	EUDAMED	Class IIa	Active
Magic Needle	INC20G70	EUDAMED	Class IIa	Active