Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006993514

FEI Number

3006993514

Entity Name

AboCom Systems, Inc.

City/State/Country

Zhunan Township Miaoli, TW

Establishment Address

No. 77, Youyi Rd, Zhunan Township Miaoli 35059, TW

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

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

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

Registered Product Listings

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

Official Correspondent

No official correspondent registered.

US Agent Details

Rafael Agiv Email: rafi.agiv@rocotosolutions.com Phone: (949) 6897863

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
3035371773	Rocoto Inc.	Irvine, CA, US
3014730563	ROCOTO LTD.	Raanana Central, IL

Similar Registrations

Registration Number	Establishment Name	Location
3013682780	RONIN SURGICAL CORP.	Austin, TX, US
3035371773	Rocoto Inc.	Irvine, CA, US
1000379039	HEINE OPTOTECHNIK GMBH & CO. KG.	GILCHING Bavaria, DE
3014342096	KARL STORZ SE & CO KG	TUTTLINGEN Baden-Wurttemberg, DE
3007662989	DENTMATE TECHNOLOGY CO., LTD.	New Taipei, TW

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006993514. Last updated year: 2026. Please use registration number 3006993514 when referencing this establishment in official correspondence.