Identity
- Trade Name
- Skin IQ MCM EUDAMEDSKIN IQ FDA UDI
- Generic Name
- External circulating-air core temperature regulation system pad, single-use FDA UDI
- Device Name
- ALPHA ACTIVE 3 PUMP EUDAMEDSkin IQ Microclimate Manager - Mattress Coverlet Only, 1 Pack FDA UDI
- Model / Reference
- SIQCOSTS1UN EUDAMEDFDA UDI648305BG EUDAMED
- Description
- Skin IQ Microclimate Manager - Mattress Coverlet Only, 1 Pack FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055982782999 EUDAMEDFDA UDI
- Basic UDI-DI
- 5060693520020VD EUDAMED
- FDA Product Code
- IOQ FDA UDI
- EMDN Code
- Z12019003 WOUND TREATMENT EQUIPMENT EUDAMED
- GMDN Term
- External circulating-air core temperature regulation system pad, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 890.5170 FDA UDI
- Market of Registration
- Northern Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
Yes
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: External circulating-air core temperature regulation system pad, single-use
Skin Iq by Arjohuntleigh, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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
- Arjohuntleigh, Inc.
Sources (2)
- FDA UDI 27f21104-b722-4e52-afb7-855809f61532 33 fields · synced Jun 18, 2026
- EUDAMED f0870c0a-5e79-4167-886f-57e3ae355f09 61 fields · synced Jun 18, 2026