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Navilloon-E
EUDAMEDClass I (EU MDR)
Ref Navilloon-e, Catalog ver. 2Model MG-BC-0601ERef Navilloon-e / Catalog ver. 2Model MG-BC-0601E, MG-BC-0301E
Identity
- Trade Name
- NAVILLOON-E EUDAMED
- Device Name
- NAVILLOON-E EUDAMEDSterile Single-use Balloon Catheter for Eustachian tube Dilatation EUDAMED
- Model / Reference
- MG-BC-0601E EUDAMEDNavilloon-e, Catalog ver. 2 EUDAMEDMG-BC-0601E, MG-BC-0301E EUDAMEDNavilloon-e / Catalog ver. 2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18800029901826 EUDAMED18800029901833 EUDAMED
- Basic UDI-DI
- B-18800029901826 EUDAMED88000299SNSS11RW EUDAMED
- EMDN Code
- Q030308 ENT SURGERY DILATORS, SINGLE-USE 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
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
Navilloon-E by Mega Medical Co., Ltd. — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-18800029901826 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-18800029901826 | Class I | Active |
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Manufacturer
- Manufacturer
- Mega Medical Co., Ltd.
- EUDAMED SRN
- KR-MF-000008718
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (4)
- EUDAMED edef2bfd-078f-4bb6-901c-5b86a6b67804 61 fields · synced Jul 20, 2026
- EUDAMED edef2bfd-078f-4bb6-901c-5b86a6b67804-1 61 fields · synced Jun 9, 2026
- EUDAMED 2567fb38-ff7d-4cb7-9e90-15841a20ebc8 61 fields · synced Jun 19, 2026
- EUDAMED eaaca4df-bad8-4654-84f7-c3610676ec85 61 fields · synced Jul 20, 2026