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ShockPulse SPL-CSL

by Gyrus Acmi, Inc.

Ref SPL-CSL

ShockPulse SPL-CSL is a device classified as Class I in the EU and Class II in the US made by Gyrus Acmi, Inc., registered in EUDAMED on 22 Jul 2026 (Basic UDI-DI 08219250000155) and listed in FDA GUDID since 3 Mar 2020 (UDI-DI 00821925043671), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08219250000155 Basic UDI-DI 00821925043671UDI-DIDate22 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00821925043671 UDI-DI Date3 Mar 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08219250000155 registered 22 Jul 2026 Active
  • FDA GUDID UDI-DI 00821925043671 listed 3 Mar 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00821925043671
  2. Registered EUDAMED 08219250000155

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
ShockPulse
Generic name
Pneumatic/ultrasonic lithotripsy system
Device name
ShockPulse lithotripsy accessories (nosecone, wrench, stylet)
Model / reference
SPL-CSL
Primary DI / UDI-DI
00821925043671
Basic UDI-DI
08219250000155
Direct marketing DI
00821925043671
FDA product code
FEO
EMDN code
Z12010880 Instruments for ultrasonic surgery - hardware accessories
GMDN term
Pneumatic/ultrasonic lithotripsy system
Device class
Class I EUDAMED
Class II GUDID
Regulation number
876.4480
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II
Sterilise before useEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 00821925043671: EUDAMED states Yes, FDA GUDID states No.

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Pneumatic/ultrasonic lithotripsy system

Similar devices in this category

Other devices filed under INSTRUMENTS FOR ULTRASONIC SURGERY - HARDWARE ACCESSORIES.

Other devices from Gyrus Acmi, Inc.

See all devices from Gyrus Acmi, Inc. →

Properties

  • Sterilise before use YesEUDAMEDNoGUDID
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)