| Reference / SKU | DI 01-538-01 |
| Material | AISI 304 / AISI 316 austenitic surgical-grade stainless steel |
| Sterilization | Steam autoclave to 134 °C · EtO compatible |
| Quality system | ISO 13485:2016 · CE-marked under EU MDR 2017/745 · FDA establishment-registered |
ZOELLNER Suction Tube · SKU DI 01-538-01 — manufactured to ISO 13485:2016.
- Mac Polio Fiber Optic Laryngoscope Blade (DI 01-293-01)
- McCoy Flexible Tip Laryngoscope Blades
- Sekar Mirror Fiber Optic Laryngoscope Blade (DI 01-294-01)
Diagnostic instruments cover the examination tools used in clinic settings: stethoscopes, otoscopes, ophthalmoscopes, percussion hammers, tuning forks, tongue depressors, and specialty examination patterns for specific anatomy (nasal specula, ear specula, vaginal specula). The diagnostic category sits between consumables and durable equipment — the patterns are reusable, autoclavable where applicable, and built to outlast many years of clinical use. Material requirements vary: examination instruments in contact with mucosa (specula, sound dilators, tongue depressors) use AISI 304 or AISI 316 austenitic stainless for corrosion resistance and biocompatibility; reflex hammers and tuning forks use bronze or specialty alloys for the acoustic and mechanical properties required. Fizza supplies the full diagnostic instrument range under ISO 13485:2016.
Manufacturing compliance is verified through ISO 13485:2016 certification (the international medical-device quality standard), CE marking under EU MDR 2017/745, and FDA establishment registration. Certificate copies and regulatory documentation are available on request for inclusion in hospital procurement files and EU technical documentation packages. Sterilization validation follows ISO 17665 for steam autoclave at 134 °C.



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