Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013735622

FEI Number

3013735622

Entity Name

PERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETI

City/State/Country

Izmir, TR

Establishment Address

Buca OSB Mah. 2/20 Sok. No:9 BEGOS Buca, Izmir 35400, TR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

PERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETI (Owner Number: 10055386)

Owner / Operator Contact Address

Buca OSB Mah. 2/20 Sok. No:9 BEGOS Buca, ?zmir, TR-35 35400, TR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Face Mask 3 - Ply Comfort Clear Vision Comfort Face Shield Clear Vision Comfort Face Shield Eco Clear Vision Comfort Face Shield L Clear Vision Comfort Face Shield Eco L Suction Liner System Clear Vision Lens Basic Clear Vision Frame Black Clear Vision Frame Blue Clear Vision Frame White Clear Vision Lens Easy Peel Clear Vision Frame Red Clear Vision Frame Yellow Clear Vision Frame Mixed Colours Clear Vision Lens DS Probe Cover 14 x 40 cm Probe Cover with Adhesive 15 x 245 cm Probe Cover with Adhesive 15 x 120 cm Probe Cover 14 x 160 cm Probe Cover 14 x 120 cm Probe Cover with Adhesive 12 x 60 cm Probe Cover 14 x 80 cm Probe Cover 14 x 25 cm Probe Cover with Adhesive 18x120 cm Probe Cover with Adhesive 18x160 cm Probe Cover with Adhesive 18x40 cm Probe Cover 14 x 250 cm Probe Cover with Adhesive 18x120 cm (Gel) Probe Cover with Adhesive 18x80 cm Probe cover 18x120 cm Probe cover 18x30 cm Probe Cover with Adhesive 18x80 cm (Gel) Probe Cover 14 x 120 cm Bulk (Individually PE Packed) Probe Cover with Adhesive 18x160 cm (Gel) Camera Drape Telescopic Folded with Perforated Tip & Insert Card 15x250 cm Probe cover 18x120 cm (Gel) Camera Drape Ring Folded with Adhesive Closure 15x250 cm Camera Drape Telescopic Folded with Perforated Tip 13x250 cm Probe cover with Adhesive 18x30 cm (Gel) Probe cover 18x30 cm (Gel) Probe Cover 14x250 cm (Gel) Probe Cover 14x120 cm (Gel)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2020-08-07
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-04-09
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2017-07-20
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2020-03-23
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2019-02-07

Official Correspondent

Ozan Baran

US Agent Details

Robert Patane Business: J & P Management Company LLC Email: bob@hpsrx.com Phone: (540) 3759380

Related Public Records

Same Entity

PERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETI

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013735622. Last updated year: 2026. Please use registration number 3013735622 when referencing this establishment in official correspondence.