← Back to catalogue
Silicone Nasal Epistaxis Balloon
EUDAMEDFDA UDIClass I (EU MDR)
Ref 3103-0930Model 3101-0830
Identity
- Trade Name
- Silicone Nasal Epistaxis Balloon EUDAMEDEpistaxis balloon catheter FDA UDI
- Generic Name
- Nasal haemostatic catheter FDA UDI
- Device Name
- Silicone Nasal Epistaxis Balloon EUDAMEDsilicone sterile, 1 piece/box FDA UDI
- Model / Reference
- 3103-0930 EUDAMEDFDA UDI3101-0830 EUDAMED
- Description
- silicone sterile, 1 piece/box FDA UDI
Identifiers
- Catalog Number
- 3103-0930 FDA UDI
- Primary DI / UDI-DI
- 04711182605483 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04711182605483 EUDAMED471096193111201FG EUDAMED
- FDA Product Code
- EMX FDA UDI
- EMDN Code
- Q030201 EPISTAXIS CATHETERS EUDAMED
- GMDN Term
- Nasal haemostatic catheter FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 874.4100 FDA UDI
- Market of Registration
- Germany EUDAMEDPoland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
No
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
Yes
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
No
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-04711182605483 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-04711182605483 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fortune Medical Instrument Corp.
- EUDAMED SRN
- TW-MF-000009221
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 6811e79a-2794-499c-b3e9-c08120075db1 61 fields · synced Jul 15, 2026
- FDA UDI e31f2aaa-7217-4831-87b2-4f5e259a0011 35 fields · synced May 24, 2026
- EUDAMED 8d0cec37-20b7-4340-ad49-62bf90a83822 61 fields · synced Jun 19, 2026