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ri-former® extension module ri-thermo® N with wall support and anti-theft proof
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- ri-former® extension module ri-thermo® N with wall support and anti-theft proof FDA UDI
- Generic Name
- Infrared patient thermometer, ear FDA UDI
- Device Name
- The thermometers are for measuring the body temperature. FDA UDI
- Model / Reference
- 3656-301 FDA UDI
- Description
- The thermometers are for measuring the body temperature. FDA UDI
Identifiers
- Catalog Number
- 3656-301 FDA UDI
- Primary DI / UDI-DI
- 04045396152977 FDA UDI
- 510(k) Number
- K020725 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
Yes
FDA UDI
Category: Infrared patient thermometer, ear
ri-former® extension module ri-thermo® N with wall support and anti-theft proof by Rudolf Riester GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID
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
K020725 also covers:
- ri-former® extension module ri-thermo® N with wall support — Rudolf Riester GmbH & Co. KG
- ri-thermo® N multifunctional infrared thermometer with 25 disposable probe cover — Rudolf Riester GmbH & Co. KG
- ri-thermo® N professional thermometer with dispenser and 100 probe covers — Rudolf Riester GmbH & Co. KG
- ri-thermo® N professional thermometer, with dispenser 100 probe covers, MEDLINE — Rudolf Riester GmbH & Co. KG
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
- Rudolf Riester GmbH & Co. KG
Sources (1)
- FDA UDI db5aecab-1e52-4f9d-8bfb-50eafb294394 35 fields · synced Jun 6, 2026