Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018366468

FEI Number

3018366468

Entity Name

XINLE HUABAO MEDICAL DEVICES CO.,LTD

City/State/Country

Xinle City Hebei, CN

Establishment Address

No.16 SanYuan Road., Xinle City Hebei 050700, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Xinle Huabao Medical Devices Co.,Ltd (Owner Number: 10081020)

Owner / Operator Contact Address

No.16 SanYuan Road., Xinle City, CN-HE 050700, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Back Table Cover/Table Cover/BTC

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2024-07-29

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

Xinle Huabao Medical Devices 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 3018366468. Last updated year: 2026. Please use registration number 3018366468 when referencing this establishment in official correspondence.