Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9710154

FEI Number

3003347293

Entity Name

Q-MED AB

City/State/Country

UPPSALA, SE

Establishment Address

SEMINARIEGATAN 21, UPPSALA SE-752 28, SE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Q-MED AB (Owner Number: 9042143)

Owner / Operator Contact Address

SEMINARIEGATAN 21, --, UPPSALA, SE-C SE-752 28, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P030050

All Registered Proprietary Names

Solesta Restylane-L Restylane Silk Perlane Restylane Restylane Lyft with Lidocaine Barrigel Restylane Refyne Restylane Defyne Restylane Kysse Restylane Contour Sculptra

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LNM	Agent, Bulking, Injectable For Gastro-Urology Use	Unknown	Class 3	N/A	2011-10-17
LMH	Implant, Dermal, For Aesthetic Use	Unknown	Class 3	N/A	2007-12-13
PKY	Implant, Dermal, For Aesthetic Use In The Hands	Unknown	Class 3	N/A	2007-12-13
OVB	Hydrogel Spacer	Radiology	Class 2	892.5725	2022-07-18
LMH	Implant, Dermal, For Aesthetic Use	Unknown	Class 3	N/A	2017-02-21
LMH	Implant, Dermal, For Aesthetic Use	Unknown	Class 3	N/A	2023-03-17

Official Correspondent

No official correspondent registered.

US Agent Details

Randy Russell Business: Galderma Laboratories L.P Email: Randy.Russell@galderma.com Phone: (817) 9615146

Related Public Records

Same Entity

Q-MED AB

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-0040-06	Boston Scientific Corporation	3	Enteryx Procedure Kit Order No.: M00572600 -US and M00572500 -OUS

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9710154. Last updated year: 2026. Please use registration number 9710154 when referencing this establishment in official correspondence.