Identity
- Trade Name
- DORMO-SPEC EUDAMED
- Device Name
- Disposable speculum for otoscope EUDAMED
- Model / Reference
- 4040 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08427734007556 EUDAMED
- Basic UDI-DI
- 8427734OTOSCOPESPECULUMFB EUDAMED
- EMDN Code
- Z12021085 ENT ENDOSCOPY INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
Dormo-Spec by Telic, S.A.U. — 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 | 8427734OTOSCOPESPECULUMFB | Class I | Active |
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Manufacturer
- Manufacturer
- Telic, S.A.U.
- EUDAMED SRN
- ES-MF-000001853
Sources (2)
- EUDAMED 2c8273d3-33de-4248-abbc-55e8ab5dda93 61 fields · synced Jun 18, 2026
- EUDAMED 97066fcb-fdfb-4448-99b8-4b5657750ca7 61 fields · synced Jun 11, 2026