Identity
- Trade Name
- HYGEA FDA UDI
- Generic Name
- Microwave ablation system probe, electrically-powered FDA UDI
- Device Name
- Sterile Microwave Ablation Probe is used with Microwave Ablation Device, which is indicated for soft tissue coagulation (ablation) by healthcare professionals in healthcare facilities. Sterile Microwave Ablation Probe is not intended for cardiac use. FDA UDI
- Model / Reference
- Exact HC-1814100U FDA UDI
- Description
- Sterile Microwave Ablation Probe is used with Microwave Ablation Device, which is indicated for soft tissue coagulation (ablation) by healthcare professionals in healthcare facilities. Sterile Microwave Ablation Probe is not intended for cardiac use. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06935650622613 FDA UDI
- 510(k) Number
- K233140 FDA UDI
- FDA Product Code
- NEY FDA UDI
- GMDN Term
- Microwave ablation system probe, electrically-powered 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 probe, electrically-powered
Hygea by Hygea Medical Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Microwave ablation system probe, electrically-powered.
- HYGEA — Hygea Medical Technology Co., Ltd. · Class II
- HYGEA — Hygea Medical Technology Co., Ltd. · Class II
- HYGEA — Hygea Medical Technology Co., Ltd. · Class II
- HYGEA — Hygea Medical Technology Co., Ltd. · Class II
- HYGEA — Hygea Medical Technology Co., Ltd. · Class II
- HYGEA — Hygea Medical Technology Co., Ltd. · Class II
- HYGEA — Hygea Medical Technology Co., Ltd. · Class II
- HYGEA — Hygea Medical Technology Co., Ltd. · 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 aa14e98a-7bd1-4fd4-8c1b-6b033939627f 34 fields · synced May 30, 2026