← Back to catalogue

Dophi

FDA UDI

Class II (US FDA UDI)

by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.

Identity

Trade Name
Dophi FDA UDI
Generic Name
Radio-frequency ablation system FDA UDI
Device Name
Radio Frequency Electrode Kits FDA UDI
Model / Reference
SS-RFAS1-2530 FDA UDI
Description
Radio Frequency Electrode Kits FDA UDI

Identifiers

Primary DI / UDI-DI
16972304750114 FDA UDI
510(k) Number
K190052 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Radio-frequency ablation system 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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Radio-frequency ablation system

Dophi by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radio-frequency ablation system.

Cleared under the same submission

K190052 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.

Sources (1)

  • FDA UDI 42eb3313-a355-473c-8456-a51e54169014 34 fields · synced May 31, 2026