Identity
- Trade Name
- heat it pro USB-C FDA UDI
- Generic Name
- Insect bite/sting hyperthermia device FDA UDI
- Device Name
- Smartphone add-on for the symptomatic treatment of insect bites with heat. FDA UDI
- Model / Reference
- 010_00577-2 FDA UDI
- Description
- Smartphone add-on for the symptomatic treatment of insect bites with heat. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04262370293017 FDA UDI
- FDA Product Code
- IRT FDA UDI
- GMDN Term
- Insect bite/sting hyperthermia device FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5740 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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: Insect bite/sting hyperthermia device
heat it pro USB-C by Kamedi GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Insect bite/sting hyperthermia device.
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- Caring Mill — Caring Mill · Class II
- bite away — mibeTec GmbH · Class II
- Sting Doctor — Spark Innovators Corporation · Class II
- heat it for iPhone — Kamedi GmbH · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Kamedi GmbH
Sources (2)
- FDA UDI 8d73bc1e-d263-4d69-ad42-7de9a314bc7d 34 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026