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Isolite, i3

by Zyris, Inc.

Ref EIL0302-DEModel Isolite, i3, DE

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

CE MDD

Valid until

Not listed

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00810032661090 Basic UDI-DI 00810032661090UDI-DIDate3 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00810032661090 UDI-DI Date8 Apr 2024ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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

Generic Name
Dental suction system
Model / Ref / Catalog
Isolite, i3, DE, EIL0302-DE
Primary DI / UDI-DI
00810032661090
Basic UDI-DI
B-00810032661090
FDA Product Code
EBR
EMDN Code
Q019001 Saliva aspirators and saliva absorbents
GMDN Term
Dental suction system
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
872.6640
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
US-MF-000034843
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Zyris, Inc.

See all devices from Zyris, Inc. →

Properties

  • Premarket Exempt
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (18)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No