Dophi

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref SS-TP18G-20

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

Identity

Trade Name: Temperature Probe EUDAMED
Dophi FDA UDI
Generic Name: Cryosurgical system temperature probe FDA UDI
Device Name: Radiofrequency Ablation System EUDAMED
Temperature Probe FDA UDI
Model / Reference: SS-TP18G-20 EUDAMEDFDA UDI
Description: Temperature Probe FDA UDI

Identifiers

Primary DI / UDI-DI: 16972304750015 EUDAMEDFDA UDI
Basic UDI-DI: 69723047500016P EUDAMED
510(k) Number: K183153 FDA UDI
FDA Product Code: NEY FDA UDI
EMDN Code: K020380 DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - ACCESSORIES EUDAMED
GMDN Term: Cryosurgical system temperature probe FDA UDI

Classification

Device Class: Class IIb EUDAMED
Class II FDA UDI
Regulation Number: 878.4400 FDA UDI
Market of Registration: Finland 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: Cryosurgical system temperature probe

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 Cryosurgical system temperature probe.

HYGEA — Hygea Medical Technology 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

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

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

Manufacturer

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

Sources (2)

FDA UDI 90833d65-cea6-4cda-9cc1-4ad5a12ac41f 34 fields · synced Jul 14, 2026
EUDAMED 326315e0-5b45-4ecf-8e89-8951b8a6487f 61 fields · synced Jul 14, 2026