Doyen slightly concave 115mm x 45mm 240mm (24cm) Vaginal Specula

The Doyen slightly concave 115mm x 45mm 240mm (24cm) Vaginal Specula is a precision gynecological surgical instrument manufactured by Fizza Surgical in Sialkot, Pakistan. Designed for gynecological examination, colposcopy, and cervical visualization, this…

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 / AISI 316 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 GY 12-310-06 Categories ,
Regulatory Nomenclature
EMDN (EUDAMED): V0204
GMDN Code: 39814
Gynecological instrument

Doyen slightly concave 115mm x 45mm 240mm (24cm) Vaginal Specula (Ref GY 12-310-06), manufactured at the Fizza Surgical facility in Sialkot, Pakistan.

Reference / SKUGY 12-310-06
PatternDoyen
Working length115 mm (11.5 cm)
MaterialAISI 304 / AISI 316 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

Eugène-Louis Doyen, a French surgeon active in the late nineteenth and early twentieth centuries, contributed several instrument designs to the surgical canon. Doyen retractors come in two main types: the rib raspatory used in thoracic surgery to elevate the periosteum from a rib, and the abdominal retractor used during laparotomy. The rib raspatory pattern is asymmetric — left and right variants — with a curved blade that follows the rib’s profile. The abdominal Doyen has a broad curved blade that retracts viscera during exploration. Both patterns remain in use; the rib raspatory is a standard thoracic instrument used during open thoracotomy where minimally invasive approaches are not feasible.

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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