MHRA Manufacturer Compliance Statement

About G.N Surgical Ltd

G.N Surgical Ltd is a UK-registered manufacturer and supplier of reusable surgical, dental, ENT, gynaecological, and general medical instruments. We operate from Ilford, Greater London, and supply high-quality, precision-engineered instruments to healthcare professionals, training institutions, and authorised distributors.

Company Name: G.N Surgical Ltd
Company Number:
Registered Address: Flat 11A, Kingswood Road, Ilford, IG3 8UE, United Kingdom

MHRA registration

G.N Surgical Ltd is officially registered with the Medicines and Healthcare products Regulatory Agency (MHRA) as a manufacturer of Class I reusable medical devices.

MHRA Account Number: 0000025987
Registration Status: Registered
Registration Date: 05 December 2025
Application Reference: 2025120501449817

This registration confirms that our organisation has met the requirements for placing Class I reusable medical devices on the Great Britain (GB) market.

Registered device categories

The following categories of reusable medical devices are registered with the MHRA under our organisation:

• Surgical forceps (alligator, soft-tissue, dressing, utility)
• ENT instruments (speculums, suction dissectors, diagnostic sets, laryngoscope blades)
• Dental instruments (mirrors, probes, elevators, extraction forceps, spatulas, rongeurs)
• Gynaecological instruments (speculums, uterine sounds, intrauterine tools)
• Orthopaedic instruments (chisels, mallets, bone files, rongeurs, elevators)
• Scissors (surgical, nasal, tonsil, cast cutting, periodontal, ophthalmic)
• Retractors (self-retaining and handheld)
• Scalpel handles and reusable blades
• Rubber dam instruments
• General surgical tools (towel clamps, curettes, spatulas, syringes, trocars)
• Additional reusable Class I devices as listed in our MHRA registration

A full list of registered GMDN codes is available upon request.

Regulatory compliance

All reusable medical devices supplied by G.N Surgical Ltd are intended to comply with:

• UK Medical Devices Regulations 2002 (as amended)
• MHRA registration requirements for Class I devices
• Applicable UKCA or CE marking requirements (subject to applicable transition timelines)
• Good Manufacturing Practice (GMP) principles
• Internal quality control and inspection procedures

All devices are supplied non-sterile, unless otherwise stated, and must be cleaned and sterilised by the end user before clinical use.

Intended use

Our instruments are intended for use by trained professionals, including:

• Healthcare professionals and clinical institutions
• Training centres and universities
• Authorised distributors
• Veterinary professionals
• Approved medical practitioners

Devices must only be used by appropriately trained personnel in accordance with professional and local institutional guidelines.

Geographical scope

Our MHRA registration applies to Great Britain (England, Scotland, Wales). For Northern Ireland, the European Union, and other international markets, additional regulatory requirements may apply.

Quality assurance

All instruments undergo inspection and quality checks which may include:

• Visual and functional inspection
• Dimensional and performance checks, where applicable
• Material and surface finish verification
• Packaging and labelling checks
• Batch traceability

Contact information

For regulatory enquiries, documentation requests, or compliance questions, please contact:

Email: info@gnsurgical.co.uk
Address: Flat 11A, Kingswood Road, Ilford, IG3 8UE, United Kingdom
Company: G.N Surgical Ltd