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Performa® D

by Merit Medical Systems, Inc. 7 variants

Ref 1628-256/DModel Performa®

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

CE MDD

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00884450839737 UDI-DI Date23 Sep 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDD EUDAMED NumberB-00884450839737 Basic UDI-DI 00884450839737UDI-DIDate27 Aug 2026RegisteredStatusActive

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.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Performa®
Generic Name
Angiographic catheter, single-use
Device Name
Performa Angiography Catheters
Model / Ref / Catalog
Performa® EUDAMED
1628-256/D EUDAMED
D GUDID
1628-256 GUDID
Primary DI / UDI-DI
00884450839737
Basic UDI-DI
B-00884450839737
FDA Product Code
DQO
EMDN Code
C010401020101 Ptca balloon dilation catheters
GMDN Term
Angiographic catheter, single-use
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
870.1200
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Performa®
1628-256/D
GUDID
D
Device ClassEUDAMED
Class III
GUDID
Class II

Other devices from Merit Medical Systems, Inc.

See all devices from Merit Medical Systems, Inc. →

Properties

  • Sterile
  • Single Use
  • Animal Tissues
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (16)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: 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
  • Serial Number: No
  • Manufacturing Date: No