Identity
- Trade Name
- Silicone Nasal Epistaxis Balloon EUDAMED
- Model / Reference
- 3102-2010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04711182605476 EUDAMED
- Basic UDI-DI
- B-04711182605476 EUDAMED
- EMDN Code
- Q030201 EPISTAXIS CATHETERS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Silicone Nasal Epistaxis Balloon by Fortune Medical Instrument Corp. — 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-04711182605476 | Class I | Active |
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Manufacturer
- Manufacturer
- Fortune Medical Instrument Corp.
- EUDAMED SRN
- TW-MF-000009221
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED cbd08e1c-e5f8-4907-ae75-21b34c219515 61 fields · synced Jun 18, 2026