AMOENA MEDIZIN-ORTHOPADIE-TECHNIK GMBH

FDA Device Registration & Listing · RAUBLING, BAVARIA, DE · Registration 1000641183

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
1000641183
FEI Number
1000641183
Entity Name
AMOENA MEDIZIN-ORTHOPADIE-TECHNIK GMBH
City/State/Country
RAUBLING, BAVARIA, DE
Establishment Address
KAPELLENWEG 36, RAUBLING, BAVARIA D-83064, DE
Establishment Type(s)
Manufacture Medical Device
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
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Amoena PurFit Amoena Amoena Amoena

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
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
KCZ Prosthesis, Breast, External, Used With Adhesive General, Plastic Surgery Class 1 878.3800 2001-08-14

Official Correspondent

No official correspondent registered.

US Agent Details

Taimur Mehmood Business: Amoena USA Corporation Email: taimur.mehmood@amoena.com Phone: (770) 2818230

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
3005855077 Amoena USA Corporation Kennesaw, GA, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000641183. Last updated year: 2026. Please use registration number 1000641183 when referencing this establishment in official correspondence.
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