Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3025355675

FEI Number

3025355675

Entity Name

Skylla SARL

City/State/Country

Aissa Tunis, TN

Establishment Address

Boulevard de l'Envirement, Monastir, Mesjed, Aissa Tunis 5042, TN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Skylla Europe BV (Owner Number: 10086746)

Owner / Operator Contact Address

Tomeikerweg 10, Geleen, NL-NOTA RB 6161, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Arion Magnide Large Arion Magnide 2 in1 Large Arjo Easy-Slide Medium Arion Proth-Pro Arm Large Arion Dactyna Large Sigvaris Sim-Slide Medium Arion Magnide Kids Small Arion SlideX Extra Large Arjo Easy-Slide Extra Large Arion Magnide Medium Arion Proth-Pro Medium Arion Proth-Pro Extra Extra Large Arion Dactyna Medium EASY-LEVER Arion Easy-Off Made-to-measure Sigvaris Sim-Slide Small Arion Proth-Pro Large Arion Easy-Off Small Sigvaris Magnide on/off Medium Arion Proth-Pro Arm Medium Sigvaris Magnide on/off Large Arion Easy-Slide Arm Medium Arion Easy-Off Large Arion Easy-Off Medium Arion Proth-Pro Small Arion Easy-Slide Medium Arion Dactyna Kids Extra Small Arjo Easy-Slide Large Arion Proth-Pro Extra Small Arion SlideX Large Arion Easy-Slide Extra Small ArionEasy-Slide Extra Large Sigvaris Magnide on/off Extra Large Arion Proth-Pro Extra Large Arjo Easy-Slide Small Arion Magnide 2 in1 Medium Arion Easy-Slide Made-to-measure Sigvaris Sim-Slide Large Arion Easy-Slide Arm Large Arion Easy-Slide Kids Small Arion Magnide 2 in1 Extra Large Arion Easy-Slide Large Arion Proth-Pro Made-to-measure Arion SlideX Medium Arion Easy-Slide Small Arion Proth-Pro Arm Small Sigvaris Sim-Slide Extra Large Arion Easy-Slide Kids Extra Small Arion Magnide Extra Large Arion Easy-Slide Arm Made-to-measure Arion Dactyna Small Arion Magnide Made-to-measure Easy-Slide Kids Proth-Pro Arm Sim-Slide Easy-off Magnide Kids Dactyna Proth-Pro Magnide Easy-Slide Magnide 2 in1 1 Arion Trans-Slide Tri-Clean Hovermatt Air Transfer System Dactyna Kids Easy-Slide Arm Arion Trans-Slide

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IPM	Cover, Limb	Physical Medicine	Class 1	890.3025	2025-01-14
FMR	Device, Transfer, Patient, Manual	General Hospital	Class 1	880.6785	2022-12-07

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Skylla Europe BV

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3016661700	SKYLLA EUROPE BV	Geleen Limburg, NL
3036731074	Skylla Morocco Sarl	Kenitra, MA

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3025355675. Last updated year: 2026. Please use registration number 3025355675 when referencing this establishment in official correspondence.