Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008863514

FEI Number

3008863514

Entity Name

LIPOELASTIC A.S.

City/State/Country

Prague Praha, Hlavni Mesto, CZ

Establishment Address

Radlicka 608/2, Prague Praha, Hlavni Mesto 150 00, CZ

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

LIPOELASTIC a.s. (Owner Number: 10041054)

Owner / Operator Contact Address

Radlicka 608/2, Prague, CZ-10 150 00, CZ

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

LIPOELASTIC Body Suits LIPOELASTIC vests LIPOELASTIC Arm garments LIPOELASTIC - binders LIPOELASTIC Facial garments

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2012-06-15
FSD	Binder, Abdominal	General Hospital	Class 1	880.5160	2012-06-15
KMO	Binder, Elastic	General Hospital	Class 1	880.5160	2012-06-15

Official Correspondent

No official correspondent registered.

US Agent Details

Kevin Walls Business: Regulatory Insight, Inc. Email: kevin@reginsight.com Phone: (720) 9625412

Related Public Records

Same Entity

LIPOELASTIC a.s.

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 3008863514. Last updated year: 2026. Please use registration number 3008863514 when referencing this establishment in official correspondence.