Skip to content

Performa® 00884450362235

by Merit Medical Systems, Inc.

Ref 612538ULT2Model A

Performa® 00884450362235 (612538ULT2/A) 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 22 Oct 2026 (Basic UDI-DI B-00884450362235) and listed in FDA GUDID since 6 Jun 2019 (UDI-DI 00884450362235), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00884450362235 Basic UDI-DI 00884450362235UDI-DIDate22 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00884450362235 UDI-DI Date6 Jun 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00884450362235 registered 22 Oct 2026 Active
  • FDA GUDID UDI-DI 00884450362235 listed 6 Jun 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00884450362235
  2. Registered EUDAMED B-00884450362235

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  • Withdrawn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
A, 612538ULT2, 00884450362235, 00884450258910, 612538ULT2/A
Primary DI / UDI-DI
00884450362235, 00884450258910
Basic UDI-DI
B-00884450362235
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 · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
A
612538ULT2
GUDID
00884450362235
00884450258910
Device classEUDAMED
Class III
GUDID
Class II

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)