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Isolite, i3
EUDAMEDClass IIa (EU MDR)
Ref EIL0302-POLModel Isolite, i3, POL
by Zyris, Inc.
Identity
- Trade Name
- Isolite, i3 EUDAMED
- Model / Reference
- Isolite, i3, POL EUDAMEDEIL0302-POL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810032661311 EUDAMED
- Basic UDI-DI
- B-00810032661311 EUDAMED
- EMDN Code
- Q019001 SALIVA ASPIRATORS AND SALIVA ABSORBENTS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Isolite, i3 by Zyris, Inc. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00810032661311 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Zyris, Inc.
- EUDAMED SRN
- US-MF-000034843
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED cb08edd5-b17e-4cd3-a195-b6cb5434147a 61 fields · synced May 29, 2026