Identity
- Trade Name
- OTOSCOPE EUDAMED
- Device Name
- OTOSCOPE EUDAMED
- Model / Reference
- FMO-001-7100-90.01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08964003352769 EUDAMED
- Basic UDI-DI
- 8964003352HM185U EUDAMED
- EMDN Code
- Z12021007,Z12149006 EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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 by Haymed Instruments — 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 | 8964003352HM185U | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Haymed Instruments
- EUDAMED SRN
- PK-MF-000012992
- Authorised Representative
- International Business Compendious of Sweden SE-AR-000001625
Sources (1)
- EUDAMED 77b58b8e-6b21-4993-8798-d55778a4d383 61 fields · synced Jun 19, 2026