Dophi

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref SS-MWA-1531C

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

Identity

Trade Name: Microwave Ablation Electrode Kits EUDAMED
Dophi FDA UDI
Generic Name: Microwave ablation system probe, non-powered FDA UDI
Device Name: Microwave Ablation System EUDAMED
Microwave Ablation Electrode Kits FDA UDI
Model / Reference: SS-MWA-1531C EUDAMEDFDA UDI
Description: Microwave Ablation Electrode Kits FDA UDI

Identifiers

Primary DI / UDI-DI: 16972304750251 EUDAMEDFDA UDI
Basic UDI-DI: 69723047500026R EUDAMED
510(k) Number: K183153 FDA UDI
FDA Product Code: NEY FDA UDI
EMDN Code: Z120608 MICROWAVE THERAPY EQUIPMENT EUDAMED
GMDN Term: Microwave ablation system probe, non-powered FDA UDI

Classification

Device Class: Class IIb EUDAMED
Class II FDA UDI
Regulation Number: 878.4400 FDA UDI
Market of Registration: Spain EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

Yes

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Microwave ablation system probe, non-powered

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

Similar devices

Also classified as Microwave ablation system probe, non-powered.

Microwave Ablation Antennas — Canyon Medical Inc. · Class IIb
TempSure System, Surgical — Cynosure, LLC · Class IIb
Microwave Ablation Antennas — Canyon Medical Inc. · Class IIb
SURGITRON 4.0 DUAL RF/90 IEC 220-240V — Cynosure, LLC · Class IIb
Swift® — Emblation , Ltd. · Class I
Microwave Ablation Antennas — Canyon Medical Inc. · Class IIb
Microwave Ablation Antennas — Canyon Medical Inc. · Class IIb
Microwave Ablation Antennas — Canyon Medical Inc. · Class IIb

Cleared under the same submission

K183153 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

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

Sources (2)

FDA UDI ec212d92-4791-48f1-812f-1f39f33f9da7 34 fields · synced Sep 18, 2026
EUDAMED 7bcf7a1b-f514-4e2f-b52b-5b281c1572ec 61 fields · synced Sep 18, 2026