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ColdSPOT

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 502SRef 500

by Beekley Corporation

Identity

Trade Name
ColdSPOT EUDAMEDFDA UDI
Generic Name
Hot/cold therapy pack, single-use FDA UDI
Device Name
ColdSPOT EUDAMED
Cold Therapy Packs, 2.0x3.0" gel pack, with Florals FDA UDI
Model / Reference
502S EUDAMEDFDA UDI
500 EUDAMED
Description
Cold Therapy Packs, 2.0x3.0" gel pack, with Florals FDA UDI

Identifiers

Primary DI / UDI-DI
00815137021985 EUDAMEDFDA UDI
10815137021074 EUDAMED
Basic UDI-DI
00815137021985CW EUDAMED
00815137021077BJ EUDAMED
FDA Product Code
IMD FDA UDI
EMDN Code
M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
GMDN Term
Hot/cold therapy pack, single-use FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Regulation Number
890.5710 FDA UDI
Medical Purpose
Cold Therapy Packs EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

ColdSPOT by Beekley Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Beekley Corporation
EUDAMED SRN
US-PR-000044332

Sources (3)

  • EUDAMED e95aac80-5d66-4d79-8cb4-6af94186e05b 61 fields · synced Sep 18, 2026
  • EUDAMED bce9293c-c0c9-46ec-8fa7-8ce24dcbe1c9 61 fields · synced May 18, 2026
  • FDA UDI 68a4f025-e5d9-46ea-a25d-bd93908658cc 33 fields · synced May 26, 2026