Identity
- Trade Name
- otoscope EUDAMED
- Device Name
- otoscope EUDAMED
- Model / Reference
- LTI-3000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08964004416002 EUDAMED
- Basic UDI-DI
- 8964004416LTI-3000PS EUDAMED
- EMDN Code
- Z12021007 MIDDLE EAR OTOSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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
Category: Otoscope, endoscopic
otoscope by Laftan Trading International — 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 | 8964004416LTI-3000PS | Class I | Active |
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Manufacturer
- Manufacturer
- Laftan Trading International
- EUDAMED SRN
- PK-MF-000047531
- Authorised Representative
- KHANG BAO INTERNATIONAL KFT HU-AR-000034102
Sources (1)
- EUDAMED abde5f39-3f37-426b-9d42-00da10be3a26 61 fields · synced Jun 18, 2026