Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3044905088

FEI Number

3044905088

Entity Name

SHANGHAI MAXFLEX MEDICAL TECHNOLOGY CO., LTD.

City/State/Country

Shanghai, CN

Establishment Address

Building 1, 1169 Yuanqu Road, Anting Town, Jiading District, Shanghai, China, Shanghai 201805, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shanghai Maxflex Medical Technology Co., Ltd. (Owner Number: 10095404)

Owner / Operator Contact Address

Building 1, 1169 Yuanqu Road, Anting Town, Jiading District, Shanghai, China, Shanghai, CN-SH 201805, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Thermoforming sheet:M-LA-100-F133-100-E M-LE-100-F125-063-N Thermoforming sheet: T-DALA-181-F133-100-N T-EADA-111-F125-076-N Thermoforming sheet: T-ECDA-343-S127-076-N T-ECDA-343-S127-100-E Thermoforming sheet: M-EC-100-F120-050-C M-EC-100-F125-100-N M-EC-100-F125-076-N M-EC-100-F125-063-N Thermoforming sheet: M-EC-BW1-100-F125-100-E M-LA-100-F120-076-E M-LA-100-F120-063-E Thermoforming sheet: T-ECDA-343-F125-076-E T-ECDA-343-F125-076-K Thermoforming sheet:T-EADA-111-S127-100-E T-ECDA-343-F120-100-N Thermoforming sheet: M-LA-100-F125-063-N M-LA-100-F125-076-N M-LA-100-F125-076-E M-LA-100-F125-100-N Thermoforming sheet: M-EC-BW1-F120-050-E M-EC-BW1-F125-050-N M-EC-BW1-F125-050-C Thermoforming sheet:T-ECDA-343-F120-076-K T-ECDA-343-F120-076-N Thermoforming sheet:T-ECDA-343-F125-063-P T-ECDA-343-F125-100-P T-ECDA-343-F125-063-K Thermoforming sheet: T-DALA-181-F125-076-N T-DALA-181-F125-063-N Thermoforming sheet: M-EC-BW1-100-F125-050-C M-EC-BW1-100-F125-063-E M-EC-BW1-100-F125-076-E Thermoforming sheet: T-ECDA-343-F125-063-E T-ECDA-343-F125-100-E Thermoforming sheet: T-ECDA-343-F133-076-P T-ECDA-343-F133-100-P Thermoforming sheet: T-EADA-111-R105-076-N T-EADA-111-R105-076-E Thermoforming sheet: T-ECDA-343-F125-100-K T-ECDA-343-F125-089-E Thermoforming sheet: T-EADA-111-R137-076-N T-EADA-111-R137-076-E Thermoforming sheet: T-ECDA-343-S102-089-E T-ECDA-343-S102-089-N Thermoforming sheet: T-ECDA-343-R102-076-N T-ECDA-343-R102-076-E Thermoforming sheet:M-EC-100-S127-076-E M-EC-BA1-F120-076-N Thermoforming sheet: D-LMEA-460-F125-100-H D-LMEA-550-F125-200-H D-LMEA-550-F125-060-E Thermoforming sheet: M-EC-100-F125-040-N M-EC-100-F125-100-E Thermoforming sheet: T-EADA-111-S102-089-E T-EADA-111-S102-100-N T-EADA-111-S102-100-E T-EADA-111-S127-076-N Thermoforming sheet: M-LE-100-F125-076-N M-LE-100-F125-076-E M-LE-100-F125-100-E M-LE-100-F133-076-E Thermoforming sheet:M-LA-100-F125-040-C M-LA-100-F125-100-E Thermoforming sheet: M-EC-100-F125-063-E M-EC-100-F125-050-E M-EC-100-F125-050-C Thermoforming sheet: T-ECDA-343-F133-076-E T-ECDA-343-F133-063-P Thermoforming sheet: T-DALA-181-F120-063-N T-DALA-181-F120-100-E T-DALA-181-F120-100-N Thermoforming sheet:T-ECDA-343-F125-076-N T-ECDA-343-F125-076-P Thermoforming sheet: T-EADA-111-F125-089-E T-EADA-111-F125-100-N Thermoforming sheet: M-LE-100-F133-076-N T-DAEA-181-F120-076-N Thermoforming sheet: T-ECDA-343-F125-089-N T-ECDA-343-F133-076-K Thermoforming sheet: M-EC-100-F120-076-N M-EC-100-F120-063-N M-EC-100-F120-100-E Thermoforming sheet:M-CS-100-F125-070-N M-EC-100-F120-100-N Thermoforming sheet: T-ECDA-343-R137-076-N T-ECDA-343-R137-076-E Thermoforming sheet: M-EC-100-S102-100-E M-EC-100-S102-076-E M-EC-100-S127-100-N Thermoforming sheet: T-EADA-111-S127-076-E T-EADA-111-S127-089-N Thermoforming sheet: T-ECDA-343-R105-076-N T-ECDA-343-R105-076-E Thermoforming sheet:T-ECDA-343-F120-063-K T-ECDA-343-F120-100-K Thermoforming sheet:T-DALA-181-F125-100-E T-DALA-181-F125-100-N T-DALA-181-F133-100-E Thermoforming sheet:T-EADA-111-S102-076-N T-EADA-111-S102-076-E T-EADA-111-S102-089-N Thermoforming sheet: M-EC-100-F120-076-E M-EC-100-F120-040-N Thermoforming sheet: M-LA-100-F125-063-E M-LA-100-F133-100-N M-LA-100-F133-040-C Thermoforming sheet: T-ECDA-343-S127-100-N T-ECDA-343-S127-076-E Thermoforming sheet: M-LA-100-F120-040-C M-LA-100-F120-100-E Thermoforming sheet: T-ECDA-343-F133-089-E T-ECDA-343-S102-100-N Thermoforming sheet:M-EC-100-F133-040-C M-EC-100-F133-050-C Thermoforming sheet: T-DAEA-181-F120-063-N T-DAEA-181-F125-076-N T-DAEA-181-F125-063-N T-DALA-181-F120-076-N Thermoforming sheet: T-ECDA-343-F133-063-E Thermoforming sheet: T-ECDA-343-F120-063-E T-ECDA-343-F120-100-E Thermoforming sheet:T-ECDA-343-S102-100-E Thermoforming sheet: M-EC-100-S102-100-N M-EC-100-S102-076-N Thermoforming sheet:T-EADA-111-F125-100-E T-EADA-111-F133-076-N Thermoforming sheet: M-EC-100-S127-076-N M-EC-100-S127-100-E Thermoforming sheet: M-EC-100-F133-076-E M-EC-100-F133-100-E M-EC-100-F133-063-E Thermoforming sheet:T-EADA-111-F125-076-E T-EADA-111-F125-089-N Thermoforming sheet: T-EADA-111-F133-076-E T-EADA-111-F133-089-N Thermoforming sheet:M-EC-BA1-F125-100-E M-EC-BW1-F120-050-N Thermoforming sheet: T-EADA-111-R102-076-N T-EADA-111-R102-076-E Thermoforming sheet: T-ECDA-343-F125-100-N T-ECDA-343-F125-063-N Thermoforming sheet: D-LMEA-370-F120-130-H D-LMEA-460-F120-100-H D-LMEA-550-F120-200-H D-LMEA-370-F125-130-H Thermoforming sheet: T-ECDA-343-F133-100-E T-ECDA-343-F133-089-N Thermoforming sheet: M-EC-100-F120-050-E M-EC-100-F120-063-E M-EC-100-F120-040-C Thermoforming sheet: M-EC-BA1-F120-076-E M-EC-BA1-F120-100-N Thermoforming sheet: T-ECDA-343-S102-076-E T-ECDA-343-S102-076-N Thermoforming sheet: T-ECDA-343-S127-089-E T-ECDA-343-S127-089-N Thermoforming sheet:M-EC-100-F125-076-E M-EC-100-F125-040-C Thermoforming sheet: M-EC-BA1-F120-100-E M-EC-BA1-F125-076-E Thermoforming sheet: T-EADA-111-F133-089-E T-EADA-111-F133-100-N T-EADA-111-F133-100-E Thermoforming sheet: T-ECDA-343-F120-063-N T-ECDA-343-F120-076-E Thermoforming sheet: T-ECDA-343-F120-076-P T-ECDA-343-F120-063-P T-ECDA-343-F120-100-P Thermoforming sheet: T-ECDA-343-F133-063-K T-ECDA-343-F133-100-K Thermoforming sheet: M-LA-100-F133-050-C M-LA-100-F133-063-E M-LA-100-F133-076-E Thermoforming sheet: T-EADA-111-S127-089-E T-EADA-111-S127-100-N Thermoforming sheet: M-LA-100-F125-040-N M-LA-100-F125-050-N

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DYT	Maintainer, Space Preformed, Orthodontic	Dental	Class 1	872.5525	2026-03-09

Official Correspondent

Julie Li

US Agent Details

Laura Lautner Business: Intelli-Med Technology Co.,Ltd Email: us.agent@intelli-med.cn Phone: (626) 2470943

Related Public Records

Same Entity

Shanghai Maxflex Medical Technology 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 3044905088. Last updated year: 2026. Please use registration number 3044905088 when referencing this establishment in official correspondence.