Skip to content

Penumbra System SCH1

by Penumbra, Inc.

Ref SCH1Model Penumbra Smart Coil Detachment Handle

Penumbra System SCH1 is a device classified as Class I in the EU and Class II in the US made by Penumbra, Inc., registered in EUDAMED on 27 May 2026 (Basic UDI-DI 081454801SCHEV), cleared under FDA 510(k) K143218 on 18 Mar 2015 and listed in FDA GUDID since 30 Jul 2016 (UDI-DI 00815948027596), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K143218

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081454801SCHEV Basic UDI-DI 00815948027596UDI-DIDate27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00815948027596 UDI-DI Date30 Jul 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK143218 Date18 Mar 2015DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 081454801SCHEV registered 27 May 2026 Active
  • FDA 510(k) K143218 decided 18 Mar 2015 Active
  • FDA GUDID UDI-DI 00815948027596 listed 30 Jul 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K143218
  2. Listed FDA GUDID 00815948027596
  3. Registered EUDAMED 081454801SCHEV

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Penumbra Smart Coil Detachment Handle EUDAMED
Penumbra System GUDID
Generic name
Embolization implant kit
Device name
Detachment Handle
Model / reference
SCH1, Penumbra Smart Coil Detachment Handle
Primary DI / UDI-DI
00815948027596 EUDAMED
00814548016139 GUDID
Basic UDI-DI
081454801SCHEV
510(k) Number
FDA product code
HCG
EMDN code
C010402020301 Embolisation coils
GMDN term
Embolization implant kit
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.5950
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
Primary DI / UDI-DIEUDAMED
00815948027596
GUDID
00814548016139
Device classEUDAMED
Class I
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00815948027596; FDA GUDID lists 00814548016139), so their flags are not compared. 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: Embolization implant kit

Cleared under the same submission (K143218)

and 8 more cleared under K143218

Similar devices in this category

Other devices filed under EMBOLISATION COILS.

Other devices from Penumbra, Inc.

See all devices from Penumbra, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Lot / batch number
  • Serial number
  • Expiration date
Other properties (19, all answered No)