Identity
- Trade Name
- EN-672 OTONAM 200 EUDAMED
- Device Name
- EQUIPO FUTURA PLUS EUDAMED
- Model / Reference
- EN-660 EUDAMEDEN-672 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08437023142417 EUDAMED
- Basic UDI-DI
- 08437023142UNIDTRATZ8 EUDAMED
- EMDN Code
- Z121402 ENT TREATMENT UNITS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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: ENT examination/treatment system
En-672 Otonam 200 by Namrol Medical, S.l. — 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 | 08437023142UNIDTRATZ8 | Class I | Active |
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Manufacturer
- Manufacturer
- Namrol Medical, S.l.
- EUDAMED SRN
- ES-MF-000006718
Sources (1)
- EUDAMED b289cb17-577a-4805-a5f4-4d0f656320d5 61 fields · synced Jul 8, 2026