Identity
- Trade Name
- Betters (Suzhou)Medical Co., Ltd. FDA UDI
- Generic Name
- Microwave ablation system generator FDA UDI
- Model / Reference
- BD-GT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975283420095 FDA UDI
- 510(k) Number
- K232240 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
No
FDA UDI
Single Use
No
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
Yes
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
Category: Microwave ablation system generator
Betters (Suzhou)Medical Co., Ltd. by Betters(Suzhou) Medical Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Microwave ablation system generator.
- Emprint — Covidien LP · Class II
- MicroThermX Microwave Ablation System — PERSEON CORPORATION · Class II
- NEUWAVE — NeuWave Medical, Inc. · Class I
- HYGEA — Hygea Medical Technology Co., Ltd. · Class II
- 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
Cleared under the same submission
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
- Betters(Suzhou) Medical Co., Ltd.
Sources (1)
- FDA UDI a49c406b-45bc-43bf-9837-da87d51063e9 33 fields · synced May 30, 2026