← Back to catalogue
Vacuum Lever Set, i3
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref PIL0306
by Zyris, Inc.
Identity
- Trade Name
- Isolite, i3 FDA UDI
- Generic Name
- Dental suction system FDA UDI
- Device Name
- Vacuum Lever Set, i3 EUDAMEDFDA UDI
- Model / Reference
- PIL0306 EUDAMEDFDA UDI
- Description
- Vacuum Lever Set, i3 FDA UDI
Identifiers
- Catalog Number
- PIL0306 FDA UDI
- Primary DI / UDI-DI
- 00810032660802 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00810032660802 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
- Germany 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Vacuum Lever Set, 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-00810032660802 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zyris, Inc.
- EUDAMED SRN
- US-MF-000034843
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 5ca2975a-7a8c-4856-99f0-d1ba86a2d990 61 fields · synced Jul 9, 2026
- FDA UDI ef1224ed-dd8e-4ca9-8ac8-9c599ae83d7e 35 fields · synced May 30, 2026