Identity
- Trade Name
- HYGEA FDA UDI
- Generic Name
- Microwave ablation system generator FDA UDI
- Device Name
- The Sterile Temperature Probe is intended to be used in conjunction with the Exceed S10U microwave ablation device manufactured by Hygea Medical Technology Co., Ltd. to measure the temperature of solid tumors and surrounding tissues. FDA UDI
- Model / Reference
- Ease TSL08A FDA UDI
- Description
- The Sterile Temperature Probe is intended to be used in conjunction with the Exceed S10U microwave ablation device manufactured by Hygea Medical Technology Co., Ltd. to measure the temperature of solid tumors and surrounding tissues. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06935650626468 FDA UDI
- 510(k) Number
- K233140 FDA UDI
- FDA Product Code
- NEY FDA UDI
- GMDN Term
- Microwave ablation system generator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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 Unsafe FDA UDI
Category: Microwave ablation system generator
Hygea by Hygea Medical Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Microwave ablation system generator.
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- NEUWAVE — NeuWave Medical, Inc. · Class I
- MicroThermX Microwave Ablation System — ENDOCARE, INC. · Class II
- Dophi — Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. · Class II
- Mima-Pro — Mima-Pro (Nan Tong) Scientific Inc. · Class II
- NEUWAVE — NeuWave Medical, Inc. · Class I
- MicroThermX Microwave Ablation System — Varian Medical Systems, Inc · Class II
Cleared under the same submission
K233140 also covers:
- HYGEA — Hygea Medical Technology Co., Ltd.
- HYGEA — Hygea Medical Technology Co., Ltd.
- HYGEA — Hygea Medical Technology Co., Ltd.
- HYGEA — Hygea Medical Technology Co., Ltd.
- HYGEA — Hygea Medical Technology Co., Ltd.
- HYGEA — Hygea Medical Technology Co., Ltd.
- HYGEA — Hygea Medical Technology Co., Ltd.
- HYGEA — Hygea Medical Technology Co., Ltd.
- HYGEA — Hygea Medical Technology Co., Ltd.
- HYGEA — Hygea Medical Technology Co., Ltd.
- HYGEA — Hygea Medical Technology Co., Ltd.
- HYGEA — Hygea 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 |
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Manufacturer
- Manufacturer
- Hygea Medical Technology Co., Ltd.
Sources (1)
- FDA UDI d9169ab6-c70b-414b-b935-eb125498c4c8 34 fields · synced Jun 8, 2026