Identity
- Trade Name
- OTOSCOPE SET EUDAMED
- Device Name
- OTOSCOPE SET EUDAMED
- Model / Reference
- OTOSCO.1 / 745-096 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 89640040179570 EUDAMED
- Basic UDI-DI
- 8964004017OTOSCO.1DH EUDAMED
- EMDN Code
- Z12021007 MIDDLE EAR OTOSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Otoscope Set by Metech International — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 8964004017OTOSCO.1DH | Class I | Active |
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Manufacturer
- Manufacturer
- Metech International
- EUDAMED SRN
- PK-MF-000041396
- Authorised Representative
- KHANG BAO INTERNATIONAL KFT HU-AR-000034102
Sources (1)
- EUDAMED 7bc9bd7f-8664-463f-9999-af97b9541b0b 61 fields · synced Jul 20, 2026