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ColdSPOT

by Beekley Corporation 5 variants

Ref 502

ColdSPOT (502) is a Class I device made by Beekley Corporation, registered in EUDAMED on 13 Jan 2025 (Basic UDI-DI 00815137021084BF) and listed in FDA GUDID since 22 Jul 2019 (UDI-DI 00815137021084), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

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

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number00815137021084BF Basic UDI-DI 00815137021084UDI-DIDate13 Jan 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00815137021084 UDI-DI Date22 Jul 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 00815137021084BF registered 13 Jan 2025 Active
  • FDA GUDID UDI-DI 00815137021084 listed 22 Jul 2019 Listed

Certificates

0 certificates · EUDAMED

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

Timeline

2 dated events

  1. Listed FDA GUDID 00815137021084
  2. Registered EUDAMED 00815137021084BF

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  • Withdrawn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

Generic name
Musculoskeletal hot/cold therapy pack, single-use
Model / reference
502
Primary DI / UDI-DI
00815137021084
Basic UDI-DI
00815137021084BF
FDA product code
IMD
EMDN code
M9001 Cryotherapy and thermotherapy devices
GMDN term
Musculoskeletal hot/cold therapy pack, single-use
Device class
Class I
Regulation number
890.5710
System or procedure pack
Procedure pack
EU registration type
System or procedure pack
Medical purpose
Cold Therapy Packs
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
US-PR-000044332

Related devices

Category: Hot/cold therapy pack, reusable

Similar devices in this category

Other devices filed under CRYOTHERAPY AND THERMOTHERAPY DEVICES.

Other devices from Beekley Corporation

See all devices from Beekley Corporation →

Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
Other properties (12, all answered No)