FDA.reportPublic FDA data

TEOXANE S.A.

Matched from indexed company URL: Teoxane S.A.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30059756253005975625TEOXANE S.A.1N2026-01-01Les Charmilles 105 rue de Lyon Geneva Geneve CH CH-1203

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
07640173233671RHA® 2 - """One box of RHA® 2 contains two blisters and one instruction for use. Each blister contains a 1mL prefilled syringe and two needles (30G 1/2).Box Packaging (ID 07640173233695) is defined as unit of sales and identified with a serial number."""877-373-8669Medical-us@teoxane.com
07640173233688RHA® 3 - """One box of RHA® 3 contains two blisters and one instruction for use. Each blister contains a 1mL prefilled syringe and two needles (27G 1/2).Box Packaging (ID 07640173233701) is defined as unit of sales and identified with a serial number."""877-373-8669Medical-us@teoxane.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2132041904358894P170002RHA 2, RHA 3, RHA 4LMH2017-10-19

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LMH12017-10-19

PMA#

RHA® Redensity™, RHA ®2, RHA ®3, RHA ®4 dermal fillers

2023-01-26

TEOXANE S.A.les Charmillesrue De Lyon 105geneva 1203 PMA NumberP170002 Supplement NumberS025 Date Received12/27/2022 Decision Date01/26/2023 Product Code LMH  Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Proces...

RHA Redensity, RHA 2, RHA 3, and RHA 4 dermal fillers

2022-06-14

TEOXANE S.A.les Charmillesrue De Lyon 105geneva 1203 PMA NumberP170002 Supplement NumberS021 Date Received03/17/2022 Decision Date06/14/2022 Product Code LMH  Advisory Committee General & Plastic Surgery Supplement Typereal-time Process Supplement Reason Ch...

RHA 2, RHA 3, RHA 4 dermal fillers

2022-02-24

TEOXANE S.A.rue De Lyon 105geneva 1203 PMA NumberP170002 Supplement NumberS020 Date Received01/31/2022 Decision Date02/24/2022 Product Code LMH  Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change - Man...

GUDID#