Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007739031

FEI Number

3007739031

Entity Name

VOROTEK

City/State/Country

Moolap Victoria, AU

Establishment Address

23 Point Henry Road, Moolap Victoria 3224, AU

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

VorOtek (Owner Number: 10050112)

Owner / Operator Contact Address

23 Point Henry Road, 23 Point Henry Road, Moolap, AU-VIC 3224, AU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Vorotek Speculums VorOtek O Scope VorOtek M Scope VorOtek L Scope VorOtek V Scope VorOtek LED HeadLight VorOtek X-Series HeadLight

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EPY	Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	2022-09-05
HJH	Loupe, Binocular, Low Power	Ophthalmic	Class 1	886.5120	2015-10-13
HPP	Headlamp, Operating, Battery-Operated	Ophthalmic	Class 1	886.4335	2022-02-21

Official Correspondent

Charles Vorrath

US Agent Details

Norman Black Business: Black & Black Surgical, Inc. Email: normanblack@blackandblacksurgical.com Phone: (770) 4144880

Related Public Records

Same Entity

VorOtek

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K834189	Imm Enterprises , Ltd.	JAKOBI SURG. INSTRUMENTS #7 44/47	1984-03-06

Similar Registrations

Registration Number	Establishment Name	Location
3003536766	MIQRAZ SURGICAL INDUSTRIES	Sialkot Punjab, PK
1932180	Bausch & Lomb Incorporated	Manchester, MO, US
3003334541	CONCISE ENTERPRISES	Sialkot Punjab, PK
3004892425	SPARTECH INSTRUMENTS & CO.	SIALKOT, PUNJAB, PK
9680735	HERMANN MUELLER Medizintechnik GmbH	TUTTLINGEN Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007739031. Last updated year: 2026. Please use registration number 3007739031 when referencing this establishment in official correspondence.