Identity
- Trade Name
- HYGEA FDA UDI
- Generic Name
- Cryosurgical system temperature probe FDA UDI
- Device Name
- The Sterile Temperature Probe is intended to be used in conjunction with the Co-Ablation System to measure the temperature of solid tumors excluding the cavity tumors and surrounding tissues. FDA UDI
- Model / Reference
- Ease TSS08 FDA UDI
- Description
- The Sterile Temperature Probe is intended to be used in conjunction with the Co-Ablation System to measure the temperature of solid tumors excluding the cavity tumors and surrounding tissues. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06935650602042 FDA UDI
- 510(k) Number
- K243042 FDA UDI
- FDA Product Code
- GEH FDA UDI
- GMDN Term
- Cryosurgical system temperature probe FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4350 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: Cryosurgical system temperature probe
Hygea by Hygea Medical Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cryosurgical system temperature probe.
- Dophi — Surgnova Healthcare Technologies (Zhejiang) 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
K243042 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 c8b6b2f3-e74b-4086-863b-b8008cd390f8 34 fields · synced May 31, 2026