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Body Armor® Stirrup Walker BPS2W

by DARCO International, Inc.

Ref BASWS2

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0609271040175C Basic UDI-DI 00609271040175UDI-DIDate19 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00609271040175 UDI-DI Date22 Sep 2023ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

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  • Withdrawn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
Body Armor® Stirrup Walker short EUDAMED
Body Armor® Stirrup Walker GUDID
Generic Name
Ankle/foot orthosis
Model / Ref / Catalog
BASWS2 EUDAMED
BPS2W GUDID
Primary DI / UDI-DI
00609271040175
Basic UDI-DI
0609271040175C
FDA Product Code
FZF
EMDN Code
Y06120601 Passive ankle-foot orthoses
GMDN Term
Ankle/foot orthosis
Device Class
Class I
Regulation Number
878.3900
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
BASWS2
GUDID
BPS2W

Related devices

Category: Ankle/foot orthosis

Other devices from DARCO International, Inc.

See all devices from DARCO International, Inc. →

Properties

  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (20)

  • Sterile: 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