Amoena USA Corporation

FDA Device Registration & Listing · Kennesaw, GA, US · Registration 3005855077

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
3005855077
FEI Number
3005855077
Entity Name
Amoena USA Corporation
City/State/Country
Kennesaw, GA, US
Establishment Address
1000 Cobb Place Blvd. Ste. 200, Kennesaw, GA 30144, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
AMOENA MEDIZIN-ORTHOPADIE-TECHNIK GMBH (Owner Number: 9105040)
Owner / Operator Contact Address
KAPELLENWEG 36, --, RAUBLING, BAVARIA, DE-NOTA D-83064, DE
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Amoena Amoena PurFit Amoena Amoena AmoCura Scar CuraScar Silicones Amoena

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KMO Binder, Elastic General Hospital Class 1 880.5160 2012-01-09
NOJ Prosthesis, Breast, External, No Adhesive General, Plastic Surgery Class 1 878.3800 2011-01-19
GBJ Prosthesis, Adhesive, External General, Plastic Surgery Class 1 878.3750 2002-09-06
MDA Elastomer, Silicone, For Scar Management General, Plastic Surgery Class 1 878.4025 2020-11-16
KCZ Prosthesis, Breast, External, Used With Adhesive General, Plastic Surgery Class 1 878.3800 2001-08-14

Official Correspondent

ANDREAS LINKE

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

AMOENA MEDIZIN-ORTHOPADIE-TECHNIK GMBH
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
1000641183 AMOENA MEDIZIN-ORTHOPADIE-TECHNIK GMBH RAUBLING, BAVARIA, DE

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005855077. Last updated year: 2026. Please use registration number 3005855077 when referencing this establishment in official correspondence.
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