Identity
- Trade Name
- IRIS-XP FDA UDI
- Generic Name
- Infrared thermography system FDA UDI
- Model / Reference
- IRIS FDA UDI
Identifiers
- Catalog Number
- IRIS FDA UDI
- Primary DI / UDI-DI
- 00191237000069 FDA UDI
- 510(k) Number
- K212412 FDA UDI
- FDA Product Code
- LHQ FDA UDI
- GMDN Term
- Infrared thermography system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 884.2980 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
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Infrared thermography system
Iris-Xp by Medicore, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Meditherm — Meditherm Incorporated · Class I
- Meditherm — Meditherm Incorporated · Class I
- Meditherm — Meditherm Incorporated · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Medicore, Inc.
Sources (1)
- FDA UDI 9d146c6a-6fa5-45df-b59a-5987305a24f7 36 fields · synced Jun 8, 2026