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Edwards 10000PT

by Edwards Lifesciences LLC

Ref 10000PT

Edwards 10000PT is a Class I device made by Edwards Lifesciences LLC, registered in EUDAMED on 3 Nov 2026 (Basic UDI-DI 0690103D004REU000YA) and listed in FDA GUDID since 7 Jan 2025 (UDI-DI 00690103217278), active as of 7 Nov 2026.

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

CE MDR

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/MDR EUDAMED Number0690103D004REU000YA Basic UDI-DI 00690103217278UDI-DIDate3 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00690103217278 UDI-DI Date7 Jan 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0690103D004REU000YA registered 3 Nov 2026 Active
  • FDA GUDID UDI-DI 00690103217278 listed 7 Jan 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00690103217278
  2. Registered EUDAMED 0690103D004REU000YA

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Edwards
Generic name
Cardiac implantation catheter platform base, single-use
Device name
Reusable Accessories
Model / Ref / Catalog
10000PT
Primary DI / UDI-DI
00690103217278
Basic UDI-DI
0690103D004REU000YA
Direct marketing DI
00690103217278
FDA product code
QWA
EMDN code
P0780 Vascular and cardiac prostheses - accessories
GMDN term
Cardiac implantation catheter platform base, single-use
Device class
Class I
Regulation number
870.3955
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Related devices

Category: Cardiac implantation catheter platform base, single-use

Similar devices in this category

Other devices filed under VASCULAR AND CARDIAC PROSTHESES - ACCESSORIES.

Other devices from Edwards Lifesciences LLC

See all devices from Edwards Lifesciences LLC →

Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)