Identity
- Trade Name
- Fiber Optic Otoscope Sets EUDAMED
- Device Name
- Fiber Optic Otoscope Sets Packed In Pouch In Different Colors EUDAMED
- Model / Reference
- 786-04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08964004816031 EUDAMED
- Basic UDI-DI
- 8964004816786-04QV 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
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
Fiber Optic Otoscope Sets by Surgical Appliances — 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 | 8964004816786-04QV | Class I | Active |
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Manufacturer
- Manufacturer
- Surgical Appliances
- EUDAMED SRN
- PK-MF-000042541
- Authorised Representative
- KHANG BAO INTERNATIONAL KFT HU-AR-000034102
Sources (1)
- EUDAMED 118b8f0b-12c3-4199-b4f7-a1a026372c82 61 fields · synced Jul 28, 2026