Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011389455

FEI Number

3011389455

Entity Name

TCMZONE, LLC

City/State/Country

Chandler, AZ, US

Establishment Address

2460 E Germann Rd Ste 10, Chandler, AZ 85286, US

Establishment Type(s)

Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility,Reprocess Single-Use Device

Owner / Operator

Tcmzone, LLC (Owner Number: 10092909)

Owner / Operator Contact Address

2460 East Germann Road, STE 10, Chandler, AZ 85286, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

TCM ZONE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MQX	Needle, Acupuncture, Single Use	General Hospital	Class 2	880.5580	2025-03-05

Official Correspondent

Dan Wen

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Tcmzone, LLC

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 3011389455. Last updated year: 2026. Please use registration number 3011389455 when referencing this establishment in official correspondence.