Econolith E2000

FDA UDI

Class II (US FDA UDI)

by Medispec, Ltd.

Identity

Trade Name: Econolith E2000 FDA UDI
Generic Name: Electrohydraulic lithotripsy system FDA UDI
Model / Reference: SW-7-A999 FDA UDI

Identifiers

Primary DI / UDI-DI: 07290016498257 FDA UDI
PMA Number: P950043 FDA UDI
FDA Product Code: LNS FDA UDI
GMDN Term: Electrohydraulic lithotripsy system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.5990 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Electrohydraulic lithotripsy system

Econolith E2000 by Medispec, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrohydraulic lithotripsy system.

EHL-Probe — Walz Elektronik GmbH · Class II
Autolith Uro-Touch — Northgate Technologies Inc. · Class II
EHL-Probe — Walz Elektronik GmbH · Class II
Electrohydraulic Lithotriptor — Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. · Class II
CyberWand — Gyrus Acmi, Inc. · Class II
Autolith Touch — Northgate Technologies Inc. · Class II
EL27-Compact — Walz Elektronik GmbH · Class II
EHL Probe — Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
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: Medispec, Ltd.

Sources (1)

FDA UDI bd318767-35b2-4198-9177-2a1b912549de 33 fields · synced May 30, 2026