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Pressure Controller Cover Pccvr

by Edwards Lifesciences LLC

Ref PCCVR

Pressure Controller Cover Pccvr is a device classified as Class I in the EU and Class II in the US made by Edwards Lifesciences LLC, registered in EUDAMED on 30 Sep 2026 (Basic UDI-DI 0690103D001HSA000T3) and listed in FDA GUDID since 8 Feb 2017 (UDI-DI 00690103197891), active as of 25 Oct 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0690103D001HSA000T3 Basic UDI-DI 00690103197891UDI-DIDate30 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00690103197891 UDI-DI Date8 Feb 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0690103D001HSA000T3 registered 30 Sep 2026 Active
  • FDA GUDID UDI-DI 00690103197891 listed 8 Feb 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00690103197891
  2. Registered EUDAMED 0690103D001HSA000T3

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  • Withdrawn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
Pressure Controller Cover
Generic name
Cable/lead/sensor/probe cover, non-sterile
Device name
HemoSphere Accessories
Model / Ref / Catalog
PCCVR
Primary DI / UDI-DI
00690103197891
Basic UDI-DI
0690103D001HSA000T3
FDA product code
DXN
EMDN code
Z1203020280 Multi-parameter monitors - hardware accessories
GMDN term
Cable/lead/sensor/probe cover, non-sterile
Device class
Class I EUDAMED
Class II GUDID
Regulation number
870.1130
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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: Cable/lead/sensor/probe cover, non-sterile

Similar devices in this category

Other devices filed under MULTI-PARAMETER MONITORS - HARDWARE 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)