Identity
- Trade Name
- iProven FDA UDI
- Generic Name
- Infrared patient thermometer, ear FDA UDI
- Device Name
- DMT-511GR measure baby's temperature by a quick swipe across the forehead and by ear,give accurate measurement within a second. FDA UDI
- Model / Reference
- DMT-511GR FDA UDI
- Description
- DMT-511GR measure baby's temperature by a quick swipe across the forehead and by ear,give accurate measurement within a second. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08719699632257 FDA UDI
- 510(k) Number
- K181215 FDA UDI
- FDA Product Code
- FLL FDA UDI
- GMDN Term
- Infrared patient thermometer, ear 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, ear
iProven by Sevenground Trading B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Infrared patient thermometer, ear.
- Famidoc — Famidoc Technology Company Limited · Class II
- Braun — KAZ USA, INC. · Class II
- Clever Choice — SIMPLE DIAGNOSTICS · Class II
- Braun — KAZ USA, INC. · Class II
- Bytech — Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd. · Class II
- WowGoHealth IR Ear Thermometer with Bluetooth GSH-BTS301 — GOLDEN SMART HOME TECHNOLOGY CORP. · Class II
- Easy@Home Infrared Ear Thermometers — EASY HEALTHCARE CORPORATION · Class II
- Clever Choice — SIMPLE DIAGNOSTICS · Class II
Cleared under the same submission
K181215 also covers:
- AMPMED — AMPLIM, LLC
- AMPMED — AMPLIM, LLC
- Care One — Ahold U.S.A., Inc.
- Pro Comfort Tempa Check 4-in-1 Infrared thermometer — HOME AIDE DIAGNOSTICS, INC.
- LIVIN — LIVIN WELLNESS, LLC
- Finicare — SHENZHEN FINICARE CO., LTD.
- Clever Choice — SIMPLE DIAGNOSTICS
- iProven — Sevenground Trading B.V.
- iProven — Sevenground Trading B.V.
- Finicare — Shenzhen Finicare Co., Ltd
- Finicare — Shenzhen Finicare Co., Ltd
- Finicare — Shenzhen Finicare Co., Ltd
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
- Sevenground Trading B.V.
Sources (1)
- FDA UDI 4e8dce50-9b30-4556-953f-3009745bcc9f 34 fields · synced May 30, 2026