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Custom Smart Seal AK 28-6

by Alps South, LLC 2 variants

Ref SADT28-6-C

Active European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Overview

Introducing the Custom Smart Seal AK 28-6, a innovative medical device designed to provide secure and reliable sealing of surgical incisions. This device features a unique self-testing mechanism that ensures accurate testing results without the need for sterile equipment or personnel.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00713980012559 UDI-DI Date30 Dec 2024ListedStatusListed GUDID: not in commercial distribution
European UnionCE/MDR EUDAMED Number07139801000100979 Basic UDI-DI 00713980012559UDI-DIDate27 Jun 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Custom Smart Seal AK 28-6 EUDAMED
Smart Seal Liner GUDID
Generic Name
External limb prosthesis socket liner
Model / Reference
SADT28-6-C
Primary DI / UDI-DI
00713980012559
Basic UDI-DI
07139801000100979
FDA Product Code
ISS
EMDN Code
Y062499 Lower extremity prostheses - other
GMDN Term
External limb prosthesis socket liner
Device Class
Class I
Regulation Number
890.3420
EU market of registration
Italy
GUDID distribution status
Not in Commercial Distribution

Manufacturer details

EUDAMED SRN
US-MF-000001260
Authorised representative
AR Experts B.V. NL-AR-000023989

Other devices from Alps South, LLC

See all devices from Alps South, LLC →

Properties

  • Premarket Exempt
  • Lot / Batch Number

Other properties (22)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No