Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011453824

FEI Number

3011453824

Entity Name

THERATECHNOLOGIES INC.

City/State/Country

Montreal Quebec, CA

Establishment Address

1550 Metcalfe Street, Suite 810, Montreal Quebec H3A1X6, CA

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Repack or Relabel Medical Device

Owner / Operator

Theratechnologies Inc. (Owner Number: 10062736)

Owner / Operator Contact Address

2015 Peel Street, Suite 1100, Montreal, CA-QC H3A1T8, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K161170

PMA Number

N/A

All Registered Proprietary Names

Injection box of EGRIFTA SV 2 mg/vial Injection box of EGRIFTA SV 2 mg/vial

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2020-03-17
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2020-03-17

Official Correspondent

Harley Cunha

US Agent Details

Melissa L. Goodhead Business: Pharmaceutical Project Solutions, Inc. Email: mgoodhead@PHARMAPROJECTSOLUTIONS.COM Phone: (813) 9279302

Related Public Records

Same Entity

Theratechnologies Inc.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

Similar Registrations

Registration Number	Establishment Name	Location
3027338968	RONCADELLE OPERATIONS SRL	Castel Mella Brescia, IT
3029328631	PEGASUS IMPORTS	Houston, TX, US
3021067373	VVT MED Ltd	Kfar Saba Central, IL
3009249481	JMS Co.,Ltd. Miyoshi Plant	Miyoshi Hiroshima, JP
1416980	BAXTER HEALTHCARE CORPORATION	ROUND LAKE, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011453824. Last updated year: 2026. Please use registration number 3011453824 when referencing this establishment in official correspondence.