Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010386003

FEI Number

3010386003

Entity Name

XIAMEN OTI ELECTRONIC INDUSTRY CO., LTD.

City/State/Country

Xiamen Fujian, CN

Establishment Address

BLDG.10 No. 3701 Xiang'an North Rd. Xiang'an Dist., Xiamen Fujian 361009, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Xiamen OTI Electronic Industry Co., Ltd. (Owner Number: 10044615)

Owner / Operator Contact Address

BLDG.10 No. 3701 Xiang'an North Rd. Xiang'an Dist., Xiamen, CN-FJ 361009, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

HeadStrap

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BTK	Strap, Head, Gas Mask	Anesthesiology	Class 1	868.5560	2013-07-03

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Xiamen OTI Electronic Industry Co., Ltd.

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 3010386003. Last updated year: 2026. Please use registration number 3010386003 when referencing this establishment in official correspondence.