Identity
- Model / Reference
- iO1 Elite EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719875381287 EUDAMED
- Basic UDI-DI
- 471987538_ELITE_DR EUDAMED
- EMDN Code
- Z12021007 MIDDLE EAR OTOSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Otoscope, endoscopic
iO1 Elite by SyncVision Technology Corp. — Class I — 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 | 471987538_ELITE_DR | Class I | Active |
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Manufacturer
- Manufacturer
- SyncVision Technology Corp.
- EUDAMED SRN
- TW-MF-000031890
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 7849e420-519b-46ab-9572-fd7624d01791 61 fields · synced Jul 10, 2026