Identity
- Trade Name
- Otorhinolaryngology EUDAMED
- Device Name
- ENT (Otorhinolaryngology) EUDAMED
- Model / Reference
- ENT 02 EUDAMEDSYN-ENT02-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05065021834046 EUDAMED
- Basic UDI-DI
- 5065021834SYNPP004Z7 EUDAMED
- EMDN Code
- V0599 CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- Provides specialized tools for ear, nose, and throat surgical procedures while maintaining sterility. EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Category: Ophthalmic surgical procedure kit, non-medicated, single-use
Otorhinolaryngology by SYNDEO Medical — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5065021834SYNPP004Z7 | Class IIa | Active |
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Manufacturer
- Manufacturer
- SYNDEO Medical
- EUDAMED SRN
- BE-PR-000044136
Sources (1)
- EUDAMED 87c5a9d2-b4cf-45c1-b696-9203d793d8fc 61 fields · synced Sep 18, 2026