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DARCO® Bungee wrist brace 9BW1R

by DARCO International, Inc.

Ref 9BW1R

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0609271101154U Basic UDI-DI 00609271101159UDI-DIDate19 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00609271101159 UDI-DI Date8 Feb 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  • Withdrawn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
Bungee wrist brace EUDAMED
DARCO® Bungee wrist brace GUDID
Generic Name
Wrist/hand orthosis
Model / Ref / Catalog
9BW1R, BW1-R
Primary DI / UDI-DI
00609271101159
Basic UDI-DI
0609271101154U
FDA Product Code
ILH
EMDN Code
Y060612 Wrist-hand orthoses
GMDN Term
Wrist/hand orthosis
Device Class
Class I
Regulation Number
890.3475
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Related devices

Category: Wrist/hand 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