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Breeze BE LCEN 21 D3

by College Park Industries, Inc.

Ref BE RTEN 26 G3Model MYFOOT1988

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
European UnionCE/MDR EUDAMED Number08417471MYFOOT1988AN Basic UDI-DI 00841747186196UDI-DIDate30 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841747186196 UDI-DI Date28 Jun 2023ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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
Breeze
Generic Name
Mechanical-resistance external ankle-foot prosthesis
Model / Reference
MYFOOT1988 EUDAMED
BE RTEN 26 G3 EUDAMED
BE LCEN 21 D3 GUDID
Primary DI / UDI-DI
00841747186196 EUDAMED
00841747185144 GUDID
Basic UDI-DI
08417471MYFOOT1988AN
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
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
MYFOOT1988
BE RTEN 26 G3
GUDID
BE LCEN 21 D3
Primary DI / UDI-DIEUDAMED
00841747186196
GUDID
00841747185144

Related devices

Category: Mechanical-resistance external ankle-foot prosthesis

Other devices from College Park Industries, Inc.

See all devices from College Park Industries, Inc. →

Properties

  • Premarket Exempt
  • Serial Number
  • Manufacturing Date

Other properties (21)

  • 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
  • Lot / Batch Number: No
  • Expiration Date: No