PerfectCut Aortotomy System RCK45: CE/MDD Class IIa

Regulatory status

as of registry sync 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDD EUDAMED	NumberB-10634624344508 Basic UDI-DI 10634624344508UDI-DI	Date8 Sep 2026Registered	StatusActive
United States	GUDID listing GUDID	Number10634624344508 UDI-DI	Date10 Oct 2019Listed	StatusListed GUDID: in commercial distribution

Official records

EUDAMED public site Basic UDI-DI B-10634624344508 — open Devices and search for it
AccessGUDID record UDI-DI 10634624344508

Across registries

2 registries list this device

EUDAMED Basic UDI-DI B-10634624344508 registered 8 Sep 2026 Active
FDA GUDID UDI-DI 10634624344508 listed 10 Oct 2019 Listed

Timeline

2 dated events

10 Oct 2019 Listed FDA GUDID 10634624344508
8 Sep 2026 Registered EUDAMED B-10634624344508

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDD Active
United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name: PerfectCut® Aortotomy System, 4.5 mm EUDAMED
PerfectCut Aortotomy System GUDID
Generic name: Aorta punch, single-use
Device name: .
Model / Ref / Catalog: RCK-45 EUDAMED
RCK45 GUDID

Primary DI / UDI-DI: 10634624344508
Basic UDI-DI: B-10634624344508
FDA product code: DWS
EMDN code: C01901201 Aortic punches
GMDN term: Aorta punch, single-use

Device class: Class IIa EUDAMED
Class I GUDID
Regulation number: 870.4500
EU registration type: Legacy device (under a directive)
EU market of registration: Italy
GUDID distribution status: In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

Field	EUDAMED	GUDID
Model / reference	EUDAMED RCK-45	GUDID RCK45
Device class	EUDAMED Class IIa	GUDID Class I

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