DIGNITANA AB

FDA Device Registration & Listing · Lund Skane, SE · Registration 3008888703

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
3008888703
FEI Number
3008888703
Entity Name
DIGNITANA AB
City/State/Country
Lund Skane, SE
Establishment Address
Traktorgranden 3, Lund Skane 22660, SE
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Dignitana Inc (Owner Number: 10050834)
Owner / Operator Contact Address
10925 Estate LN, Suite W-185, Dallas, TX 75238, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
DEN150010
PMA Number
N/A

All Registered Proprietary Names

DigniCap

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PMC Scalp Cooling System General, Plastic Surgery Class 2 878.4360 2016-01-11

Official Correspondent

No official correspondent registered.

US Agent Details

Alexandra Sheldrake Email: alexandra@paxmanscalpcooling.com Phone: (469) 9175555

Related Public Records

Same Entity

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

Other Registrations for Same Entity

Registration Number Establishment Name Location
3012146457 Dignitana, Inc. Dallas, TX, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008888703. Last updated year: 2026. Please use registration number 3008888703 when referencing this establishment in official correspondence.
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