Identity
- Trade Name
- Otoscope EUDAMED
- Device Name
- Otoscopes EUDAMED
- Model / Reference
- FMO-001-8300-1090 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08964003751654 EUDAMED
- Basic UDI-DI
- 8964003248FS0373 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 SG Manufacturers — 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 | 8964003248FS0373 | Class I | Active |
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Manufacturer
- Manufacturer
- SG Manufacturers
- EUDAMED SRN
- PK-MF-000007106
- Authorised Representative
- International Business Compendious of Sweden SE-AR-000001625
Sources (1)
- EUDAMED 6b72b603-01f6-47ce-952a-1d95063b87b2 61 fields · synced Aug 2, 2026