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Affinity™ CP

by Medtronic, Inc.

Ref AP40AST, HC150A

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B00000056Q Basic UDI-DI Date15 Jan 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00763000301323 UDI-DI Date31 May 2020ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

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  • Withdrawn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
Affinity™ CP
Affinity™
Generic Name
Centrifugal circulatory assist pump, manual
Cardiopulmonary bypass system centrifugal pump
Device Name
Affinity CP Adapter
Affinity Emergency Handcrank
Model / Reference
AP40AST, HC150A
Primary DI / UDI-DI
00763000301323, 00763000301330
Basic UDI-DI
0763000B00000056Q, 0763000B00000066S
510(k) Number
FDA Product Code
DWA, KFM
EMDN Code
C030180 Extracorporeal and assisted circulation devices - accessories
GMDN Term
Centrifugal circulatory assist pump, manual
Cardiopulmonary bypass system centrifugal pump
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
870.4380, 870.4360
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Weight — 3.2 Kilogram
Outer Diameter — 94.0 Millimeter
Height — 28.0 Millimeter
Weight — 315.0 Gram

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000019977
Authorised representative
Medtronic B.V. NL-AR-000006050

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →

Properties

  • Prescription Use
  • Serial Number

Other properties (22)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No