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EHL Probe

FDA UDI

Class II (US FDA UDI)

by Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.

Identity

Trade Name
EHL Probe FDA UDI
Generic Name
Electrohydraulic lithotripsy system FDA UDI
Model / Reference
SCDG - AS FDA UDI

Identifiers

Primary DI / UDI-DI
06973204210787 FDA UDI
510(k) Number
K243032 FDA UDI
FDA Product Code
FFK FDA UDI
GMDN Term
Electrohydraulic lithotripsy system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.4480 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Electrohydraulic lithotripsy system

EHL Probe by Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrohydraulic lithotripsy system.

Cleared under the same submission

K243032 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.

Sources (1)

  • FDA UDI 5363893d-c9c5-4aa5-85df-34ef89b71223 33 fields · synced Jun 8, 2026