Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3035371773

FEI Number

3035371773

Entity Name

Rocoto Inc.

City/State/Country

Irvine, CA, US

Establishment Address

8 Mason, Irvine, CA 92618, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Rocoto Ltd. (Owner Number: 10087616)

Owner / Operator Contact Address

Zarhin 26, Raanana, IL-M 4366250, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MD 62 System Receiver MD 11 System Receiver MD 62 System Transmitter MD 11 System Transmitter MD 52 System Transmitter MD 52 System Receiver HM11 Device SL11 System Camera Unit SL11 System Sterilizable Cover

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2023-03-21
HPP	Headlamp, Operating, Battery-Operated	Ophthalmic	Class 1	886.4335	2025-03-26
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2023-07-18

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Rocoto Ltd.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3006993514	AboCom Systems, Inc.	Zhunan Township Miaoli, TW
3014730563	ROCOTO LTD.	Raanana Central, IL

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3002725312	AMERICAN PORTWELL TECHNOLOGY, INC.	Fremont, CA, US
3007832484	JWP MANUFACTURING	Santa Clara, CA, US
3037966017	HEALTH DATA WORKS	Ponte Vedra Beach, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3035371773. Last updated year: 2026. Please use registration number 3035371773 when referencing this establishment in official correspondence.