HEDONIST BIOCHEMICAL TECHNOLOGIES CO., LTD.

FDA Device Registration & Listing · TAIPEI, TW · Registration 3003524577

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
3003524577
FEI Number
3003524577
Entity Name
HEDONIST BIOCHEMICAL TECHNOLOGIES CO., LTD.
City/State/Country
TAIPEI, TW
Establishment Address
6F, NO. 208, RUEI-GUANG ROAD, TAIPEI 114, TW
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
HEDONIST BIOCHEMICAL TECHNOLOGIES CO., LTD. (Owner Number: 9052873)
Owner / Operator Contact Address
6F, NO. 208, RUEI-GUANG ROAD, --, TAIPEI, TW-NOTA 114, TW
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

ERIC LUO Business: LODESTAR PRODUCTS, INC. Email: ECWLUO@GMAIL.COM Phone: (214) 2438218

Related Public Records

Same Entity

HEDONIST BIOCHEMICAL TECHNOLOGIES CO., LTD.
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 3003524577. Last updated year: 2026. Please use registration number 3003524577 when referencing this establishment in official correspondence.
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