LithoClast
by E.M.S. Electro Medical Systems S.A. 3 variants
LithoClast (EL-212) is a Class II device made by E.M.S. Electro Medical Systems S.A., listed in FDA GUDID since 1 Sep 2016 (UDI-DI 07613353001230), registry data as of 21 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07613353001230 | Date1 Sep 2016 | StatusListed |
Official records
- AccessGUDID record 07613353001230
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Generic name
- Pneumatic/ultrasonic lithotripsy system
- Model / Ref / Catalog
- A, EL-212
- Primary DI / UDI-DI
- 07613353001230
- FDA product code
- GCX
- GMDN term
- Pneumatic/ultrasonic lithotripsy system
- Device class
- Class II
- Regulation number
- 880.6740
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization