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Bella Blankets

by Beekley Corporation 4 variants

Ref 310S

Bella Blankets (310S) is a device classified as Class I in the EU and Class II in the US made by Beekley Corporation, registered in EUDAMED on 21 Oct 2022 (Basic UDI-DI 00815137021244BD), cleared under FDA 510(k) K073262 on 26 Mar 2008 and listed in FDA GUDID since 1 Jul 2016 (UDI-DI 00815137021244), active as of 22 Oct 2026. One FDA recall is linked to it.

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 ongoing

1 closed

Documents

None, self-declared

Class I: no certifier involved

510(k) K073262

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 Number00815137021244BD Basic UDI-DI 00815137021244UDI-DIDate21 Oct 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number00815137021244 UDI-DI Date1 Jul 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK073262 Date26 Mar 2008DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 00815137021244BD registered 21 Oct 2022 Active
  • FDA 510(k) K073262 decided 26 Mar 2008 Active
  • FDA GUDID UDI-DI 00815137021244 listed 1 Jul 2016 Listed

Certificates

0 certificates · EUDAMED

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

Recalls

1 recall · FDA

    • Terminated Z-2080-2012 FDA Class II initiated 2 Jul 2012

    Imaging artifact can occur on mammogram result

Timeline

4 dated events

  1. Cleared FDA 510(k) K073262
  2. Recall initiated FDA recalls Z-2080-2012
  3. Listed FDA GUDID 00815137021244
  4. Registered EUDAMED 00815137021244BD

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  • Withdrawn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
Medical equipment/instrument drape, single-use
Model / reference
310S
Primary DI / UDI-DI
00815137021244
Basic UDI-DI
00815137021244BD
Unit of use DI
10815137021241
510(k) Number
FDA product code
IZH
EMDN code
T0210 Non-surgical drapes
GMDN term
Medical equipment/instrument drape, single-use
Device class
Class I EUDAMED
Class II GUDID
Regulation number
892.1710
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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
US-MF-000007055
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Similar devices in this category

Other devices filed under NON-SURGICAL DRAPES.

Other devices from Beekley Corporation

See all devices from Beekley Corporation →

Properties

  • Single use
  • Lot / batch number
Other properties (23, all answered No)