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Zoe+Ruth Forehead and Ear - Object Digital Thermometer
FDA UDIClass II (US FDA UDI)
by Zoe Ruth
Identity
- Trade Name
- Zoe+Ruth Forehead and Ear - Object Digital Thermometer FDA UDI
- Generic Name
- Infrared patient thermometer, ear FDA UDI
- Model / Reference
- ZR-FE501 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00863850000329 FDA UDI
- 510(k) Number
- K182133 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: Infrared patient thermometer, ear
Zoe+Ruth Forehead and Ear - Object Digital Thermometer by Zoe Ruth — 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
K182133 also covers:
- HEB in Control — H. E. BUTT GROCERY COMPANY
- AFAC — Shenzhen AOJ Medical Technology Co., Ltd.
- AOJ — Shenzhen AOJ Medical Technology Co., Ltd.
- AOJ — Shenzhen AOJ Medical Technology Co., Ltd.
- AOJ — Shenzhen AOJ Medical Technology Co., Ltd.
- AOJ — Shenzhen AOJ Medical Technology Co., Ltd.
- AOJ — Shenzhen AOJ Medical Technology Co., Ltd.
- HxhyTope — Shenzhen AOJ Medical Technology Co., Ltd.
- HxhyTope — Shenzhen AOJ Medical Technology Co., Ltd.
- Instamediq — Shenzhen AOJ Medical Technology 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zoe Ruth
Sources (1)
- FDA UDI 64228d00-6de8-4b23-86c5-f8f6121a03dd 35 fields · synced May 30, 2026