PREMIUM BRANDS GROUP, S.A

FDA Device Registration & Listing · Colon, Panama, PA · Registration 3009429841

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
3009429841
FEI Number
3009429841
Entity Name
PREMIUM BRANDS GROUP, S.A
City/State/Country
Colon, Panama, PA
Establishment Address
Calle 6ta. Avenida 5ta. Zona Libre de Colon, Panama, Colon, Panama 0301-174, PA
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
Premium Brands Group, S.A (Owner Number: 10055796)
Owner / Operator Contact Address
Calle 6ta. Avenida 5ta. Zona Libre de Colon, Panama, Colon, Panama, PA-3 0301-174, PA
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
CAT Cannula, Nasal, Oxygen Anesthesiology Class 1 868.5340 2026-05-06
BYG Mask, Oxygen Anesthesiology Class 1 868.5580 2026-05-06
NAC Dressing, Wound, Hydrophilic General, Plastic Surgery Class 1 878.4018 2025-09-16

Official Correspondent

Mark Guttman

US Agent Details

Celia Parnicky Business: SSPT Inc Email: manager@airshiptrading.com Phone: (954) 2610657

Related Public Records

Same Entity

Premium Brands Group, S.A
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Similar Registrations

Registration Number Establishment Name Location
3038913749 INVENTEUR, LLC Saint Petersburg, FL, US
3018783526 CEVA LOGISTICS NETHERLANDS BV (Venray) Oostrum Limburgh, NL
2085602 FISHER & PAYKEL HEALTHCARE, INC. IRVINE, CA, US
3015084765 GUANG DONG EDA TECHNOLOGY CO., LTD. Dongguan City Guangdong, CN
3009831876 MASIMO CORPORATION Irvine, CA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009429841. Last updated year: 2026. Please use registration number 3009429841 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.