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Isolite, i3
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref EIL0302-BENModel Isolite, i3, BENRef EIL0302-DEModel Isolite, i3, DERef EIL0302-GRCModel Isolite, i3, GRC
by Zyris, Inc.
Identity
- Trade Name
- Isolite, i3 EUDAMEDFDA UDI
- Generic Name
- Dental suction system FDA UDI
- Device Name
- Isolite, i3, DE FDA UDI
- Model / Reference
- Isolite, i3, BEN EUDAMEDEIL0302-BEN EUDAMEDIsolite, i3, DE EUDAMEDEIL0302-DE EUDAMEDFDA UDIIsolite, i3, GRC EUDAMEDEIL0302-GRC EUDAMED
- Description
- Isolite, i3, DE FDA UDI
Identifiers
- Catalog Number
- EIL0302-DE FDA UDI
- Primary DI / UDI-DI
- 00810032661267 EUDAMED00810032661090 EUDAMEDFDA UDI00810032661298 EUDAMED
- Basic UDI-DI
- B-00810032661267 EUDAMEDB-00810032661090 EUDAMEDB-00810032661298 EUDAMED
- FDA Product Code
- EBR FDA UDI
- EMDN Code
- Q019001 SALIVA ASPIRATORS AND SALIVA ABSORBENTS EUDAMED
- GMDN Term
- Dental suction system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.6640 FDA UDI
- Market of Registration
- Belgium EUDAMEDGermany EUDAMEDGreece EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Isolite, i3 by Zyris, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00810032661267 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Zyris, Inc.
- EUDAMED SRN
- US-MF-000034843
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (4)
- EUDAMED 9cf79875-e46f-47be-8112-13fcd4a7c363 61 fields · synced Aug 3, 2026
- EUDAMED 8fd2ae7d-c348-4fe1-a813-25429eb1ed32 61 fields · synced May 18, 2026
- EUDAMED 8f648622-24fd-4002-bc8b-92cac42a5a95 61 fields · synced May 19, 2026
- FDA UDI 6795f91e-2a2d-462f-93b3-436565b04289 35 fields · synced May 30, 2026