RAUMEDIC, Incorporated.

FDA Device Registration & Listing · Mills River, NC, US · Registration 3012232668

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
3012232668
FEI Number
3012232668
Entity Name
RAUMEDIC, Incorporated.
City/State/Country
Mills River, NC, US
Establishment Address
235 Broadpointe Dr, Mills River, NC 28759, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
RAUMEDIC (Owner Number: 10024509)
Owner / Operator Contact Address
Hermann-Staudinger-Str. 2, Helmbrechts, DE-BY 95233, DE
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

OrganOx Metra System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QQK Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation Unknown Class 3 N/A 2022-04-27

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

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

Other Registrations for Same Entity

Registration Number Establishment Name Location
3006942548 RAUMEDIC - Werk Zwoenitz Zwoenitz Saxony, DE
3006946348 RAUMEDIC - Muenchberg Helmbrechts Bavaria, DE

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3006946348 RAUMEDIC - Muenchberg Helmbrechts Bavaria, DE
3031365458 WOMED SAS Montpellier Herault, FR
3009999323 STORE-ALL LOGISTICS LTD Slieverue Kilkenny, IE
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012232668. Last updated year: 2026. Please use registration number 3012232668 when referencing this establishment in official correspondence.
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