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Dormo-Spec
EUDAMEDClass I (EU MDR)
Ref 4010Ref 4095Ref 4060Ref 4070Ref 4050Ref 4020Ref 4080
Identity
- Trade Name
- DORMO-SPEC EUDAMED
- Device Name
- Disposable speculum for otoscope EUDAMED
- Model / Reference
- 4010 EUDAMED4095 EUDAMED4060 EUDAMED4070 EUDAMED4050 EUDAMED4020 EUDAMED4080 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08427734007525 EUDAMED08427734009970 EUDAMED08427734007570 EUDAMED08427734007488 EUDAMED08427734007563 EUDAMED08427734007532 EUDAMED08427734007587 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 (14)
- EUDAMED a7f90c68-d093-44fb-b600-504556a4b640 61 fields · synced Jul 27, 2026
- EUDAMED bc1bd329-5f15-4e4f-8c1f-98e5f5e76e12 61 fields · synced May 16, 2026
- EUDAMED ffb8f4cb-1d8e-4a61-945a-8fa0189e84b7 61 fields · synced May 17, 2026
- EUDAMED 2b1b721b-7535-4916-9066-cdd9d48e1628 61 fields · synced May 17, 2026
- EUDAMED 771d298b-e113-4796-8577-b0dfee9d604a 61 fields · synced May 18, 2026
- EUDAMED 4e72e7fb-401f-4207-9df0-c8b3f7425c58 61 fields · synced May 18, 2026
- EUDAMED 4fd8c4b6-23c9-4ea7-a61b-074e34bf4782 61 fields · synced May 18, 2026
- EUDAMED 2d37af96-1cbc-4eaf-8a1f-2b849d70a293 61 fields · synced Jun 19, 2026
- EUDAMED 101a308f-94f4-4e0b-bf48-beeb82738f7b 61 fields · synced Jul 9, 2026
- EUDAMED 20bbfd88-8ed0-461a-89c3-20267e6ab665 61 fields · synced Jul 9, 2026
- EUDAMED 0719dbe5-cdbf-4334-948b-f26fb5954e9c 61 fields · synced Jul 9, 2026
- EUDAMED 5291685e-a7ec-48c6-8790-7fd527260881 61 fields · synced Jul 14, 2026
- EUDAMED 3004821e-7056-499e-997b-405aaa3ebaf3 61 fields · synced Jul 14, 2026
- EUDAMED eb4e52de-ce02-477e-8303-d842572a279f 61 fields · synced Jul 27, 2026