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Earloon Eustachian Tube Dilation System
EUDAMEDClass I (EU MDR)
Ref 12406Model GECS-05-020-050Model GEDS-06-020-050SModel GEDS-06-020-050Model GEBC-04-020-050Model GEBC-05-020-050Model GECD-06-020-050Model GECD-04-020-050Model GEDS-05-020-050Model GEDS-04-020-050S
Identity
- Trade Name
- Earloon Eustachian Tube Dilation System EUDAMED
- Device Name
- Earloon Eustachian Tube Dilation System EUDAMED
- Model / Reference
- GECS-05-020-050 EUDAMED12406 EUDAMEDGEDS-06-020-050S EUDAMEDGEDS-06-020-050 EUDAMEDGEBC-04-020-050 EUDAMEDGEBC-05-020-050 EUDAMEDGECD-06-020-050 EUDAMEDGECD-04-020-050 EUDAMEDGEDS-05-020-050 EUDAMEDGEDS-04-020-050S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800026510192 EUDAMED08800026513346 EUDAMED08800026513315 EUDAMED08800026510154 EUDAMED08800026510161 EUDAMED08800026510239 EUDAMED08800026510215 EUDAMED08800026513308 EUDAMED08800026513322 EUDAMED
- Basic UDI-DI
- B-08800026510192 EUDAMEDB-08800026513346 EUDAMEDB-08800026513315 EUDAMEDB-08800026510154 EUDAMEDB-08800026510161 EUDAMEDB-08800026510239 EUDAMEDB-08800026510215 EUDAMEDB-08800026513308 EUDAMEDB-08800026513322 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-08800026510192 | 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 (9)
- EUDAMED 6fe98a78-f1c1-45b0-a960-442cddf0ff78 61 fields · synced Sep 30, 2026
- EUDAMED 490e5a8f-39ed-4caa-a84e-65b43acda988 61 fields · synced May 17, 2026
- EUDAMED 094b6f2c-9b5a-42eb-9340-b26e8fc83ad8 61 fields · synced May 17, 2026
- EUDAMED 8f275f8f-91c6-4d28-9732-bbc2dbc4f92b 61 fields · synced May 18, 2026
- EUDAMED 532fed8a-aacf-4612-8095-8dd9c2a67e0b 61 fields · synced May 18, 2026
- EUDAMED beb5591f-e7f2-4128-9798-26913a8b54e2 61 fields · synced May 19, 2026
- EUDAMED 7cc78b2c-4645-4ebf-ae1c-a0bfe4fe3536 61 fields · synced May 19, 2026
- EUDAMED f529b788-7488-4124-9cc2-ab4f46a3a8d8 61 fields · synced May 19, 2026
- EUDAMED 62eedfe7-5376-41aa-9614-7ebebbb37966 61 fields · synced May 19, 2026