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D-Piece

by Bedfont Scientific Ltd

Ref D-PIECE-3Model D-Piece

D-Piece (D-PIECE-3) is a device classified as Class I in the EU and Class II in the US made by Bedfont Scientific Ltd, registered in EUDAMED on 30 Mar 2026 (Basic UDI-DI 506024686DP014P), cleared under FDA 510(k) K173238 on 4 Apr 2019 and listed in FDA GUDID since 17 Mar 2026 (UDI-DI 05060246860238), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K173238

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number506024686DP014P Basic UDI-DI 05060246860238UDI-DIDate30 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05060246860238 UDI-DI Date17 Mar 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK173238 Date4 Apr 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 506024686DP014P registered 30 Mar 2026 Active
  • FDA 510(k) K173238 decided 4 Apr 2019 Active
  • FDA GUDID UDI-DI 05060246860238 listed 17 Mar 2026 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K173238
  2. Listed FDA GUDID 05060246860238
  3. Registered EUDAMED 506024686DP014P

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name
Gas sampling line filter, reusable
Model / Ref / Catalog
D-Piece, D-PIECE-3, D-Piece™
Primary DI / UDI-DI
05060246860238
Basic UDI-DI
506024686DP014P
510(k) Number
FDA product code
CCJ
EMDN code
R040101 Antibacterial and antiviral respiratory filters
GMDN term
Gas sampling line filter, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
868.1430
EU registration type
Standard device
EU market of registration
Denmark
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
D-Piece
D-PIECE-3
GUDID
D-Piece™
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
GB-MF-000010889
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Related devices

Category: Secretion suction kit

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Other devices filed under ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS.

Other devices from Bedfont Scientific Ltd

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Properties

  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (22, all answered No)