Identity
- Trade Name
- Sinocare Non-contact Infrared Thermometer FDA UDI
- Generic Name
- Infrared patient thermometer, skin FDA UDI
- Model / Reference
- AET-R1B1-E FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06953775612203 FDA UDI
- 510(k) Number
- K180207 FDA UDI
- FDA Product Code
- FLL FDA UDI
- GMDN Term
- Infrared patient thermometer, skin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.2910 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Infrared patient thermometer, skin
Sinocare Non-contact Infrared Thermometer by Alicn Medical Shenzhen, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Infrared patient thermometer, skin.
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Cleared under the same submission
K180207 also covers:
- AMPMED — AMPLIM, LLC
- AMPMED — AMPLIM, LLC
- AFAC Non-contact Infrared Thermometer — Alicn Medical Shenzhen, Inc.
- AFAC Non-contact Infrared Thermometer — Alicn Medical Shenzhen, Inc.
- Ahorro Non-contact Infrared Thermometer — Alicn Medical Shenzhen, Inc.
- Ahorro Non-contact Infrared Thermometer — Alicn Medical Shenzhen, Inc.
- Ampmed Non-contact Infrared Thermometer — Alicn Medical Shenzhen, Inc.
- Ampmed Non-contact Infrared Thermometer — Alicn Medical Shenzhen, Inc.
- BBLOVE Non-contact Infrared Thermometer — Alicn Medical Shenzhen, Inc.
- BBLOVE Non-contact Infrared Thermometer — Alicn Medical Shenzhen, Inc.
- BBLOVE Non-contact Infrared Thermometer — Alicn Medical Shenzhen, Inc.
- BBLOVE Non-contact Infrared Thermometer — Alicn Medical Shenzhen, Inc.
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 II | Pending data |
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Manufacturer
- Manufacturer
- Alicn Medical Shenzhen, Inc.
Sources (1)
- FDA UDI 7878fda5-3de1-48c0-93eb-8a3eea18c748 33 fields · synced Jun 8, 2026