Indigo IAPS3: EU MDR Class I registered 2026, Penumbra, Inc.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number081454801INDCAN59 Basic UDI-DI 00810169721872UDI-DI	Date26 May 2026Registered	StatusActive
United States	GUDID listing GUDID	Number00810169721872 UDI-DI	Date19 Feb 2021Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK180412	Date15 May 2018Decided	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special	NumberK180105	Date8 Mar 2018Decided	StatusActive

Official records

EUDAMED public site Basic UDI-DI 081454801INDCAN59 — open Devices and search for it
AccessGUDID record UDI-DI 00814548019765
FDA 510(k) database 510(k) number K180412
FDA 510(k) database 510(k) number K180105

Across registries

3 registries list this device

EUDAMED Basic UDI-DI 081454801INDCAN59 registered 26 May 2026 Active
FDA 510(k) K180412 decided 15 May 2018 Active· +1 more in the status table
FDA GUDID UDI-DI 00810169721872 listed 19 Feb 2021 Listed

Timeline

4 dated events

8 Mar 2018 Cleared FDA 510(k) K180105
15 May 2018 Cleared FDA 510(k) K180412
19 Feb 2021 Listed FDA GUDID 00810169721872
26 May 2026 Registered EUDAMED 081454801INDCAN59

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDR Active
United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name: Penumbra ENGINE Canister – Indigo System EUDAMED
Indigo GUDID
Generic name: Surgical irrigation/aspiration pump, reusable
Device name: Penumbra ENGINE Canister
Model / reference: IAPS3, Penumbra ENGINE Canister – Indigo System

Primary DI / UDI-DI: 00810169721872 EUDAMED
00814548019765 GUDID
Basic UDI-DI: 081454801INDCAN59
510(k) Number: K180105
K180412
FDA product code: QEW, DXE
EMDN code: A060199 Surgical drainage systems - other
GMDN term: Surgical irrigation/aspiration pump, reusable

Device class: Class I EUDAMED
Class II GUDID
Regulation number: 870.5150
EU registration type: Standard device
EU market of registration: Germany
GUDID distribution status: In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

Field	EUDAMED	GUDID
Primary DI / UDI-DI	EUDAMED 00810169721872	GUDID 00814548019765
Device class	EUDAMED Class I	GUDID Class II
Supplied sterile	EUDAMED No	GUDID Yes

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00810169721872; FDA GUDID lists 00814548019765), 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.