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Silicone Nasal Epistaxis Balloon
EUDAMEDFDA UDIClass I (EU MDR)
Ref 3101-0830Ref 3103-0930
Identity
- Trade Name
- Silicone Nasal Epistaxis Balloon EUDAMEDFDA UDI
- Generic Name
- Nasal haemostatic balloon FDA UDI
- Device Name
- Silicone Nasal Epistaxis Balloon EUDAMED
- Model / Reference
- 3101-0830 EUDAMED3103-0930 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04711182605469 EUDAMED14711182605480 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04711182605469 EUDAMEDB-14711182605480 EUDAMED471096193111201FG EUDAMED
- FDA Product Code
- EMX FDA UDI
- EMDN Code
- Q030201 EPISTAXIS CATHETERS EUDAMED
- GMDN Term
- Nasal haemostatic balloon FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 874.4100 FDA UDI
- Market of Registration
- Germany EUDAMEDAustria EUDAMEDPoland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Silicone Nasal Epistaxis Balloon by Fortune Medical Instrument Corp. — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04711182605469 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-04711182605469 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 (4)
- EUDAMED 06f9ec1e-fbfe-46de-a2c2-f9baf8070c07 61 fields · synced Jul 31, 2026
- EUDAMED eb58d5ed-a40a-4fc7-a6c3-fa72a0e4b91b 61 fields · synced May 19, 2026
- FDA UDI 135fe52f-b577-48c8-b72c-dcd4d01cc9ac 32 fields · synced May 30, 2026
- EUDAMED 34f18a8c-2124-4f14-b5b0-21cce65a4e5c 61 fields · synced Jul 31, 2026