Garware Healthcare, SAS

FDA Device Registration & Listing · Santiago de los Caballeros, DO · Registration 3035597675

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
3035597675
FEI Number
3035597675
Entity Name
Garware Healthcare, SAS
City/State/Country
Santiago de los Caballeros, DO
Establishment Address
Caribbean Industrial Park, Avenida Hispanoamericana, Edificio A10 Matanzas, Santiago de los Caballeros 51000, DO
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device
Owner / Operator
Garware Healthcare, SAS (Owner Number: 10092574)
Owner / Operator Contact Address
Caribbean Industrial Park, Avenida Hispanoamericana, Edificio A10 Matanzas, Santiago de los Caballeros, DO-25 51000, DO
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Honeycomb X-Torn

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DWL Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) General Hospital Class 2 880.5780 2025-11-21
FQM Bandage, Elastic General Hospital Class 1 880.5075 2025-01-22
GAX Tourniquet, Nonpneumatic General, Plastic Surgery Class 1 878.5900 2025-01-22

Official Correspondent

Elisa Maldonado-Holmertz

US Agent Details

Elisa Maldonado-Holmertz Email: elisamh@obelixconsult.com Phone: (512) 4316069

Related Public Records

Same Entity

Garware Healthcare, SAS
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3035597675. Last updated year: 2026. Please use registration number 3035597675 when referencing this establishment in official correspondence.
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