Generic Codes for Class I Medical Devices (MHRA) - Medical Device Design: Innovation from Concept to Market - page 336

Custom-Made Devices

K1 Dental Appliances/Prostheses

K2 Hearing Aid Inserts

K3 Prescribed Orthopedic Footwear

K4 Artificial Eyes

K5 Orthoses and Prostheses - External (Made Direct from Casts/Prescriptions)

K6 Orthopedic Implants

K7 Maxillo-Facial Devices

K8 Standing and Walking Frames

K9 Ligament and Tendon Repair Implants

K10 Spectacle Frames

Y4 Mandibular Advancement Device (Anesthetic and Respiratory Devices)

Y10 Insoles (Made Direct from Casts) (Technical Aids for Disabled Persons)

Y13 Postural Support Products (Technical Aids for Disabled Persons)

Y15 Splints (Limb/Body/Ear)/Collars (Single Use)

Procedure Packs

L1 Ward Dressing Packs

L2 Theater Dressing Packs

L3 Oral Hygiene Packs

L4 First Aid Kits

L5 Prescribed Spectacles

L6 Cerebrospinal Fluid Filter With Syringe

L7 Ophthalmic Surgical Procedure Packs

L8 Orthodontic Procedure Packs

L9 Skin Traction Kits

L10 Surgical Procedure Packs (Includes Instruments Supplied Singularly)

X5 Theatre Drape Packs (Single Use)

X6 Needle Exchange Packs (Single Use)

X11 Endoscopes/Endoscopic Instruments and Accessories (Electro-Medical Mechanical Devices)

X14 Orthoses and Prostheses Procedure Packs (Single Use)

X18 Blood Specimen Collection Kits (Single Use)

FDA Class I and II Exempt Devices

Part 862 Clinical Chemistry and Clinical Toxicology Devices

Part 864 Hematology and Pathology Devices

Part 866 Immunology and Microbiology Devices

Part 868 Anesthesiology Devices

Part 870 Cardiovascular Devices

Part 872 Dental Devices

Part 874 Ear, Nose and Throat Devices

Part 876 Gastroenterology-Urology Devices