Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012363901

FEI Number

3012363901

Entity Name

Shenzhen Lantise Technology Co., Ltd.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

Room 201, No.24 Building, the 3rd Industrial Zone, Langxia Community, Songgang Street, Bao 'an District, Shenzhen Guangdong 518105, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Remanufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Shenzhen Lantise Technology Co., Ltd. (Owner Number: 10055105)

Owner / Operator Contact Address

Room 201, No.24 Building, the 3rd Industrial Zone, Langxia Community, Songgang Street, Bao 'an District, Shenzhen, CN-GD 518105, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Dynarex 10424 Dynarex 10426 Dynarex 10432 Dynarex 10425 Dynarex 10428 Dynarex 10421 Dynarex 10422 Dynarex 10427 Dynarex 10433 Dynarex 10431 Dynarex 10420 Dynarex 10423 Dynarex 10485 Dynarex 10482 Dynarex 10481 Dynarex 10487 Dynarex Bedside Bi-fold foam floor mat DYNAREX Bed Rail Bumper

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IKY	Mattress, Flotation Therapy, Non-Powered	General Hospital	Class 1	880.5150	2017-06-07
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2017-06-07
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	2017-06-07
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2017-10-09
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2017-06-07
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2017-06-07
KIC	Cushion, Flotation	Physical Medicine	Class 1	890.3175	2017-06-07
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2023-12-22

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

Shenzhen Lantise Technology Co., Ltd.

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-2025	Ossur H F Grjothals 5 Reykjavik Iceland	1	Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012363901. Last updated year: 2026. Please use registration number 3012363901 when referencing this establishment in official correspondence.