Identity
- Trade Name
- ColdSPOT EUDAMEDFDA UDI
- Generic Name
- Hot/cold therapy pack, single-use FDA UDI
- Device Name
- ColdSPOT EUDAMEDCold Therapy Packs, 2.75x3.0" gel pack FDA UDI
- Model / Reference
- 500S EUDAMEDFDA UDI
- Description
- Cold Therapy Packs, 2.75x3.0" gel pack FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815137021978 EUDAMEDFDA UDI
- Basic UDI-DI
- 00815137021978CZ 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
Category: Hot/cold therapy pack, reusable
ColdSPOT by Beekley Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Hot/cold therapy pack, reusable.
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- reusable cold hot gel pack for Ankle — Wuhan Pakcare Bio‐technology Co.,Ltd. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 00815137021978CZ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Beekley Corporation
- EUDAMED SRN
- US-PR-000044332
Sources (2)
- EUDAMED 47446e9f-e818-4226-8997-cc43faa32851 61 fields · synced Jun 20, 2026
- FDA UDI 36e6f08f-10bc-4e64-ab9c-0452ddf1f0a1 33 fields · synced May 29, 2026