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Performa® 00884450040621

by Merit Medical Systems, Inc.

Ref 1628-E8Model D

Performa® 00884450040621 (1628-E8) is a device classified as Class III in the EU and Class II in the US made by Merit Medical Systems, Inc., registered in EUDAMED on 19 Oct 2026 (Basic UDI-DI B-00884450836224) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00884450836224), active as of 24 Oct 2026.

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

CE MDD

Valid until

No date given

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

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00884450836224 Basic UDI-DI 00884450836224UDI-DIDate19 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00884450836224 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00884450836224 registered 19 Oct 2026 Active
  • FDA GUDID UDI-DI 00884450836224 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00884450836224
  2. Registered EUDAMED B-00884450836224

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  • Withdrawn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
Model / Ref / Catalog
D, 1628-E8, 00884450040621
Primary DI / UDI-DI
00884450836224 EUDAMED
00884450040621 GUDID
Basic UDI-DI
B-00884450836224
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 registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
D
1628-E8
GUDID
00884450040621
Primary DI / UDI-DIEUDAMED
00884450836224
GUDID
00884450040621
Device classEUDAMED
Class III
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00884450836224; FDA GUDID lists 00884450040621), so their flags are not compared. Device class is stated on each registry's own scale: Class III 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: Angiographic catheter, single-use

Similar devices in this category

Other devices filed under PTCA BALLOON DILATION CATHETERS.

Other devices from Merit Medical Systems, Inc.

See all devices from Merit Medical Systems, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Contains animal tissues or cells
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)