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Edwards Stabilizer Set 10500SZ

by Edwards Lifesciences LLC EUDAMEDGUDID

Active European Union

Ref 10500SZ

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00690103219999 UDI-DIDate11 Sep 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number0690103D004PAC000S6 Basic UDI-DIDate26 Aug 2026RegisteredStatusActive

Coverage

2 jurisdictions

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  • Withdrawn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

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 on record, checked 24 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Edwards Stabilizer Set
Generic Name
Cardiac implantation catheter holder, single-use
Device Name
PASCAL Sterile Accessories
Model / Ref / Catalog
10500SZ
Primary DI / UDI-DI
00690103219999
Basic UDI-DI
0690103D004PAC000S6
FDA Product Code
QWA
EMDN Code
P0780 Vascular and cardiac prostheses - accessories
GMDN Term
Cardiac implantation catheter holder, single-use
Device Class
Class I
Regulation Number
870.3955
Market of Registration
Netherlands
GUDID distribution status
In Commercial Distribution

Other devices from Edwards Lifesciences LLC

See all devices from Edwards Lifesciences LLC →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • 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
  • Serial Number: No