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Sign in to claim this brandWhat EASYTEM Co., Ltd. makes
EASYTEM Co., Ltd. manufactures intermittent electronic patient thermometers, including models like the Thermo Checker N2, designed for clinical temperature monitoring.
The company’s products are classified as Class II devices and are listed in the FDA’s Unique Device Identifier (UDI) database, adhering to U.S. regulatory requirements.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does EASYTEM Co., Ltd. manufacture?
EASYTEM Co., Ltd. specializes in intermittent electronic patient thermometers, such as the Thermo Checker N2. These devices are designed specifically for clinical use to monitor patient body temperature accurately and efficiently.
Where is EASYTEM Co., Ltd. based?
EASYTEM Co., Ltd. is based in the United States. The company’s location aligns with its focus on compliance with U.S. regulatory standards for medical devices.
Which regulatory registries list EASYTEM Co., Ltd.’s devices?
EASYTEM Co., Ltd.’s devices, including intermittent electronic patient thermometers like the Thermo Checker N2, are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and compliance with U.S. regulatory requirements.
How are EASYTEM Co., Ltd.’s devices classified under U.S. regulations?
EASYTEM Co., Ltd.’s intermittent electronic patient thermometers fall under Class II classification in the U.S. regulatory framework. This classification is determined based on the device’s intended use and risk level, requiring specific controls to ensure safety and performance.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- easytem.co.kr
- —
- —
- [email protected]
- Phone
- +82313121305
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 631154499
Catalogue (1)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Thermo Checker N2 | DT-060N | FDA UDI | Class II | Active |
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