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Earloon Eustachian Tube Dilation System
EUDAMEDClass I (EU MDR)
Ref 12406Model GEBC-06-020-050
Identity
- Trade Name
- Earloon Eustachian Tube Dilation System EUDAMED
- Device Name
- Earloon Eustachian Tube Dilation System EUDAMED
- Model / Reference
- GEBC-06-020-050 EUDAMED12406 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800026510178 EUDAMED
- Basic UDI-DI
- B-08800026510178 EUDAMED
- EMDN Code
- Q030201 EPISTAXIS CATHETERS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Earloon Eustachian Tube Dilation System by GENOSS CO., Ltd. — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08800026510178 | Class I | Active |
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Manufacturer
- Manufacturer
- GENOSS Co., Ltd.
- EUDAMED SRN
- KR-MF-000029064
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED fff493ab-9645-4e58-8ad5-de95ab63ff25 61 fields · synced Jun 18, 2026