HEDONIST BIOCHEMICAL TECHNOLOGIES (USA), INC.

FDA Device Registration & Listing · PLANO, TX, US · Registration 3004727227

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3004727227
FEI Number
3004727227
Entity Name
HEDONIST BIOCHEMICAL TECHNOLOGIES (USA), INC.
City/State/Country
PLANO, TX, US
Establishment Address
101 East Park Boulevard, Suite #600, PLANO, TX 75074, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Hedonist Biochemical Technologies (USA), Inc. (Owner Number: 9067996)
Owner / Operator Contact Address
101 East Park Blvd, Suite #600, --, Plano, TX 75074, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K041013
PMA Number
N/A

All Registered Proprietary Names

Suile Wound Dressing Suile Ointment Wound Dressing

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FRO Dressing, Wound, Drug Unknown Class U N/A 2007-12-26
FRO Dressing, Wound, Drug Unknown Class U N/A 2007-12-26

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Hedonist Biochemical Technologies (USA), 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
K150256 Argentum Medical SILVERLON BURN CONTACT DRESSINGS 2015-04-30

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0003-06 B. Braun Medical, Inc. U
D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025 3M Company Health Care Business 3m Center U
3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004727227. Last updated year: 2026. Please use registration number 3004727227 when referencing this establishment in official correspondence.
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