Pocket Ophthalmoscope

The Pocket Ophthalmoscope is a clinical-grade ophthalmoscope for retinal examination and fundus evaluation. Used for diagnosing diabetic retinopathy, hypertensive retinopathy, glaucoma, papilledema, and other retinal conditions. Product Specifications SKU: DI-600-10…

MOQ: 50 pieces
Lead time: 18–22 working days
Sample order: 10 units · sample fee credited against first PO
OEM private label: Private-label from 300 units per SKU
Materials: AISI 304 austenitic surgical-grade stainless steel
Sterilization: Steam autoclave to 134 °C · EtO compatible
Certifications: ISO 13485:2016 · CE-marked under EU MDR 2017/745 · FDA establishment-registered
Shipping: DHL Express · UPS · FedEx · sea freight · all Incoterms

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SKU DI-600-10 Category
Regulatory Nomenclature
EMDN (EUDAMED): V040202
GMDN Code: 36031
Ophthalmoscope

Pocket Ophthalmoscope — Pocket Ophthalmoscope. Catalogue reference DI-600-10.

Catalogue features:

  • Pocket form factor for clinical examination
  • Direct illumination optical system
  • Multiple aperture / filter wheel
  • Chrome-plated knurled handle
Reference / SKUDI-600-10
Light source2.5V bulb
AperturesMultiple — including red-free filter
Power supply2 × AA batteries (not included)
PackingSoft pouch
MaterialAISI 304 austenitic surgical-grade stainless steel
SterilizationSteam autoclave to 134 °C · EtO compatible
Quality systemISO 13485:2016 · CE-marked under EU MDR 2017/745 · FDA establishment-registered

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.

What is the minimum order quantity for Fizza Surgical instruments?
Standard MOQ is 300 units per SKU for catalogue items, 500 units for fully custom designs. Sample orders of 10 units per SKU are available with the sample fee credited against the first production order.
Are Fizza Surgical instruments CE-marked and ISO 13485 certified?
Yes. All instruments are manufactured under an ISO 13485:2016 Quality Management System, CE-marked under EU MDR 2017/745, and our facility is FDA-registered. Specific certificate numbers and PDFs are on our Certifications page.
How long is the lead time and what shipping options are available?
18–22 working days for catalogue items, 28–35 days for custom designs. Shipping via DHL Express, UPS, FedEx, or sea freight on all standard Incoterms (EXW, FCA, FOB, CIF, DAP).
Can I order a custom OEM private-label run with my own branding?
Yes — private-label manufacturing from 300 units per SKU. Co-branded packaging, custom instrument-set design, and laser etching with your brand are all available.

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