TECHNICAL NOTE NO.12/2024/SEI/GQUIP/GGTPS/DIRE3/ANVISA
Products not regulated as medical devices
Products not regulated as medical devices. Published on 12/03/2020 3:34 pm Updated on 2/28/2023 5:58 pm Updated on 05/10/2022 1. Dental amalgamator 2. Equipment for making prostheses 3. Equipment for making glasses lenses 4. Fractionator , doser or mixer of solutions or medicines 5. Barcode reader 6. Tablet Making Machine 7. Material for exclusive use in laboratories for making prostheses that do not come into contact with the patient. 8. Meter for evaluating lenses ( lensometer ) or eyeglass frames 9. Health product packaging sealer 1. Microtome Knife Sharpener 2. Solution shaker 3. Laboratory shaker, except blood and its derivatives 4. Distilled water 5. Microbiology Platinum Handle 6. Water Analyzer 7. Tablet and Capsule Dissolution Analyzer 8. Particle Size Analyzer 9. Karl Fisher apparatus, except indicated for clinical diagnosis (IVD) 10. Food analysis device 11. Apparatus for determining the friability of samples 12. Electrophoresis device, except indicated for clinical diagnosis (IVD) 13. Apparatus for pyrogenic testing on guinea pigs 14. Device for water treatment, except those indicated for purifying water for use in hemodialysis, for portable use. 15. Laboratory heater 16. Non-reagent plastic or glass laboratory article, except biological sample collectors or collection containers (IVD) 17. Autoclave, except for sterilization of medical devices 18. Laboratory scale 19. Histological bath 20. Water bath, except for implants and blood bags. 21. Calorimeter, except indicated for health diagnosis 22. Anaerobic chamber 23. Laminar flow hood, except indicated for laboratory use in healthcare ( ex : hood for handling organs and tissues for transplantation) The. Chapel or cabin for preparing supplies, medicines or chemotherapy 24. Centrifuge, except indicated for use in a clinical laboratory (IVD) The. Centrifuge, except indicated for use in blood banks 25. Emergency shower and eyewash 26. Colorimeter , except indicated for clinical diagnosis (IVD) 27. Conductivity meter , except indicated for health diagnosis 28. Colony or cell counter, except indicated for clinical diagnosis (IVD) 29. Atomic particle counter, except indicated for healthcare use 30. Microscopy slide stainer , except indicated for clinical laboratory use (IVD) 31. Dye or solution for preparing samples or substances, except indicated for clinical diagnosis (IVD). 32. Cryostat, except indicated for clinical diagnosis (IVD) 33. Chromatograph, except indicated for clinical diagnosis (IVD) 34. Stopwatch for measuring reaction times 35. Densitometer , except indicated for clinical diagnosis (IVD) 36. Digester 37. Sample Diluter 38. Automatic Dispenser (for filling bottles and tubes) 39. Histology Paraffin Dispenser/Remover 40. Device for opening or sealing articles 41. Sample Management Equipment 42. Personal protective equipment for exclusive use in laboratories 43. Spectrophotometer, except indicated for clinical diagnosis (IVD) 44. Spectrometer, except indicated for clinical diagnosis (IVD) 45. Greenhouse, except for sterilization of medical devices 46. Vacuum Centrifugal Evaporator 47. Crop fermenter 48. Filter for solutions 49. Muffle furnace 50. Flame photometer 51. Solution homogenizer, except for blood and its derivatives 52. Cassette and glass slide printer. 53. Incubator, except indicated for clinical diagnosis (IVD) 54. Solution sedimentation speed indicator 55. Physical, chemical or biological indicator 56. Washer for laboratory items, except for disinfecting washers for medical products. The. Washer for laboratory items, except microplate washers and immunoassay washers (IVD) 57. Fluorescence reader, except indicated for clinical diagnosis (IVD) 58. Skin asepsis tissue 59. Freeze dryer 60. Luxmeter 61. Dissolved O2 meter in samples 62. pH meter, except indicated for clinical diagnosis (IVD) 63. Melting point meter 64. Microscope, except indicated for medical or dental procedures 65. Microtome for histology, except indicated for clinical diagnosis (IVD) 66. Laboratory furniture 67. Solid sample mill 68. Bacterial growth monitor, except indicated for clinical diagnosis (IVD) 69. Automatic slide and coverslip assemblers 70. Knives for microtomes and cryostats 71. Osmometer , except indicated for clinical diagnosis (IVD) 72. Automatic pipette 73. Manual pipette or micropipette, capillaries or microcuvettes (without reagents) 74. Heated/cooled plate for histology 75. Cotton holder 76. Paper holder 77. DNA processor, except indicated for clinical laboratory (IVD) 78. Tissue processor for histology, except indicated for clinical laboratory use (IVD) 79. Product for testing non-diagnostic application solutions 80. Radiometer, except for use in phototherapy devices 81. Container for disposal of organic waste (garbage) 82. Refractometer, except indicated for clinical diagnosis (IVD) 83. Laboratory item packaging sealer 84. Laboratory article support 85. Timer 86. Titulator 87. Viscometer, except indicated for clinical diagnosis (IVD) 1. Wheelchair cushions, except for ulcer prevention 2. Almotolia 3. Apparatus for environmental treatment or conditioning The. Air conditioners B. Air Purifier w. Air Sterilizer d. Air humidifier 4. Dental use bib 5. Bucket 6. Trays / Boxes / Cases, including for sterilization (Labels for identifying boxes/racks) 7. Barrier for separating environments 8. Screen 9. Vacuum pump 10. Boiler 11. Surgical marking pen 12. Cover for mattresses, armchairs and pillows 13. Equipment Cover 14. Compressed air plant 15. Medical gas plant 16. Central vacuum 17. Bedpan/ rim vat/ parrot/ spittoon 18. Air compressor 19. O2 concentrator, except for personal use 20. Styrofoam cutter for making molds 21. Device that destroys and disables medical/counter products (needles, scalpels, among others) 22. Device for opening an ampoule bottle 23. Device for opening medical products 24. Packaging for sterilization of medical products 25. Packaging for transport and storage of organs 26. Equipment for packaging or transporting products The. Emergency car (transport of medicines, equipment and instruments for medical procedures), except when it has a panel with electrical, hydraulic or gas connections for medical products. 27. Laundry Equipment 28. Staircase for patients, except indicated for therapy 29. Brush for cleaning products in general 30. Surgical cleaning and asepsis brush without antimicrobial 31. Hospital waste sterilizer, except for use at the healthcare procedure site 32. Food preparation stove 33. Gel for absorbing organic residues 34. Refrigerator and Freezer for general use (except for storing vaccines, blood bags, tissues and organs) 35. Steam generator 36. Plaster for making a dental model 37. Hamper (container for storing hospital clothes) and hamper bag 38. Medical waste incinerator 39. Physical, chemical or biological indicator 40. Seals, mats, supports, brushes for cleaning instruments 41. Tarpaulin/device/field for patient transfer 42. Table, chair or