Skip to content

Isolite, i2 PIL0205

by Zyris, Inc.

Ref PIL0205

Isolite, i2 PIL0205 is a device classified as Class IIa in the EU and Class I in the US made by Zyris, Inc., registered in EUDAMED on 17 Aug 2026 (Basic UDI-DI B-00810032660710) and listed in FDA GUDID since 19 Apr 2024 (UDI-DI 00810032660710), active as of 24 Oct 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00810032660710 Basic UDI-DI 00810032660710UDI-DIDate17 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00810032660710 UDI-DI Date19 Apr 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00810032660710 registered 17 Aug 2026 Active
  • FDA GUDID UDI-DI 00810032660710 listed 19 Apr 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00810032660710
  2. Registered EUDAMED B-00810032660710

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  • Withdrawn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
Isolite, i2
Generic name
Dental suction system
Device name
Vacuum Lever Set, i2
Model / Ref / Catalog
PIL0205
Primary DI / UDI-DI
00810032660710
Basic UDI-DI
B-00810032660710
FDA product code
EAZ, EBR
EMDN code
Q019001 Saliva aspirators and saliva absorbents
GMDN term
Dental suction system
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.4630, 872.6640
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 00810032660710: EUDAMED states No, FDA GUDID states Yes.

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Dental suction system

Similar devices in this category

Other devices filed under SALIVA ASPIRATORS AND SALIVA ABSORBENTS.

Other devices from Zyris, Inc.

See all devices from Zyris, Inc. →

Properties

  • Sterilise before use NoEUDAMEDYesGUDID
  • Over-the-counter
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)