Identity
- Trade Name
- easyTymp EUDAMED
- Device Name
- easyTymp EUDAMED
- Model / Reference
- easyTymp EUDAMED12467 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08054187381232 EUDAMED
- Basic UDI-DI
- 805418738IM1PMBW EUDAMED
- EMDN Code
- Z12149005 IMPEDANCE METERS FOR THE AUDITORY SYSTEM 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Impedance audiometer
easyTymp by INVENTIS S.r.l. — 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 | 805418738IM1PMBW | Class IIa | Active |
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Manufacturer
- Manufacturer
- INVENTIS S.r.l.
- EUDAMED SRN
- IT-MF-000012495
Sources (1)
- EUDAMED 9afece3e-496e-40fc-853b-51a860200093 61 fields · synced Jun 19, 2026