AURENA LABORATORIES AB

FDA Device Registration & Listing · Karlstad Varmland, SE · Registration 3006542993

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
3006542993
FEI Number
3004080052
Entity Name
AURENA LABORATORIES AB
City/State/Country
Karlstad Varmland, SE
Establishment Address
Fjarrviksvagen 22, Karlstad Varmland 65350, SE
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Aurena Laboratories AB (Owner Number: 10044962)
Owner / Operator Contact Address
Fjarrviksvagen 22, Karlstad, SE-NOTA 65350, SE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Sensi-Care Adhesive Releaser

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KCO Nasal Spray, Ent Delivery Ear, Nose, Throat Class 1 874.5220 2024-04-29
KOX Solvent, Adhesive Tape General, Plastic Surgery Class 1 878.4730 2013-09-03
KCJ Applicator, Ent Ear, Nose, Throat Class 1 874.5220 2020-01-15

Official Correspondent

No official correspondent registered.

US Agent Details

Alan Schwartz Business: mdi Consultants, Inc. Email: Alan@mdiconsultants.com Phone: (516) 4829001

Related Public Records

Same Entity

Aurena Laboratories AB
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 3006542993. Last updated year: 2026. Please use registration number 3006542993 when referencing this establishment in official correspondence.
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