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BioStep EVO, Size 25, Left, Rate 54

by Alps South, LLC

Ref BSEVO-25L-54

Active European Union. Also listed in GUDID (US).

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00713980019497 UDI-DI Date8 Jan 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number0713980100040037J Basic UDI-DI 00713980019497UDI-DIDate9 Aug 2024RegisteredStatusActive

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  • Withdrawn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
BioStep EVO, Size 25, Left, Rate 54 EUDAMED
Biostep Evo GUDID
Generic Name
Mechanical-resistance external ankle-foot prosthesis
Model / Reference
BSEVO-25L-54
Primary DI / UDI-DI
00713980019497
Basic UDI-DI
0713980100040037J
FDA Product Code
ISH
EMDN Code
Y062499 Lower extremity prostheses - other
GMDN Term
Mechanical-resistance external ankle-foot prosthesis
Device Class
Class I
Regulation Number
890.3420
EU market of registration
Italy
GUDID distribution status
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

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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