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Performa® 00884450002704

by Merit Medical Systems, Inc.

Ref 7602-61Model B

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00884450002704 Basic UDI-DI 00884450002704UDI-DIDate2 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00884450002704 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

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  • Withdrawn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
Model / Ref / Catalog
B EUDAMED
7602-61 EUDAMED
00884450002704 GUDID
7602-61/B GUDID
Primary DI / UDI-DI
00884450002704
Basic UDI-DI
B-00884450002704
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
B
7602-61
GUDID
00884450002704
Device classEUDAMED
Class III
GUDID
Class II

Related devices

Category: Angiographic catheter, single-use

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)

  • Sterilise before use: No
  • Implantable: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No
  • Prescription use: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Manufacturing date: No