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Betters (Suzhou)Medical Co., Ltd.

FDA UDI

Class II (US FDA UDI)

by Betters(Suzhou) Medical Co., Ltd.

Identity

Trade Name
Betters (Suzhou)Medical Co., Ltd. FDA UDI
Generic Name
Microwave ablation system probe, non-powered FDA UDI
Model / Reference
L-1818 FDA UDI

Identifiers

Primary DI / UDI-DI
06975283420040 FDA UDI
510(k) Number
K232241 FDA UDI
FDA Product Code
NEY FDA UDI
GMDN Term
Microwave ablation system probe, non-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

Category: Microwave ablation system probe, non-powered

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 probe, non-powered.

Cleared under the same submission

K232241 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Betters(Suzhou) Medical Co., Ltd.

Sources (1)

  • FDA UDI 42e2c3ec-0baa-46e4-a3ca-dd06315a8915 33 fields · synced Jun 1, 2026