Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004105228

FEI Number

3004105228

Entity Name

Taizhou Polus Technology Co., Ltd.

City/State/Country

Taizhou Zhejiang, CN

Establishment Address

No.58 Yongda Road, Jiangkou Street, Huangyuan District, Taizhou Zhejiang 318020, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Taizhou Polus Technology Co., Ltd. (Owner Number: 9057652)

Owner / Operator Contact Address

No.58 Yongda Road, Jiangkou Street, Huangyan District, Taizhou, CN-ZJ 318020, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Gemini® Teeth Whitening Accelerator Home Edition (BY-GM224) BEYOND® Polus® Advanced Ultra Whitening Accelerator (PLS-868UL) BEYOND® Polus® Advanced Whitening Accelerator (PLS-868A) BEYOND® II Ultra Whitening Accelerator (BE-818UL) BEYOND® II Whitening Accelerator (BE-818) BEYOND® II Cheek Retractor (5 pack) (BY-M012) BEYOND FlexiPro Cheek Retractor (5 pack) (BY-M015) BEYOND® FlexiBlue® Comfort Cheek Retractor (5 pack M Size) (BY-PD01205M) BEYOND® FlexiBlue® Comfort Cheek Retractor (5 pack L Size) (BY-PD01205L) BEYOND FlexiPro Cheek Retractor (Single pack) (BY-M016)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EEG	Heat Source For Bleaching Teeth	Dental	Class 1	872.6475	2003-07-28
EIG	Retractor, All Types	Dental	Class 1	872.4565	2007-05-25

Official Correspondent

No official correspondent registered.

US Agent Details

Victoria Pankovich Business: EAS Consulting Group, LLC Email: usagent@easconsultinggroup.com Phone: (571) 4475500

Related Public Records

Same Entity

Taizhou Polus Technology Co., Ltd.

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004105228. Last updated year: 2026. Please use registration number 3004105228 when referencing this establishment in official correspondence.