Identity
- Trade Name
- Parafleet SC 018 EUDAMEDParafleet SC 018 PTA Balloon Dilatation Catheter FDA UDI
- Generic Name
- Peripheral angioplasty balloon catheter, basic FDA UDI
- Device Name
- Minerva Pro / Parafleet SC 018 PTA Balloon Dilatation Catheter EUDAMED
- Model / Reference
- F18-050030-120 EUDAMEDrev 01 FDA UDI
Identifiers
- Catalog Number
- F18-050030-120 FDA UDI
- Primary DI / UDI-DI
- 06942265511713 EUDAMEDFDA UDI
- Basic UDI-DI
- 695848140064MH EUDAMED
- 510(k) Number
- K243704 FDA UDI
- FDA Product Code
- LIT FDA UDI
- EMDN Code
- C010402020101 PTA BALLOON DILATATION CATHETERS EUDAMED
- GMDN Term
- Peripheral angioplasty balloon catheter, basic FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1250 FDA UDI
- Market of Registration
- Netherlands 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Peripheral angioplasty balloon catheter, basic
Parafleet SC 018 by BrosMed Medical Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Peripheral angioplasty balloon catheter, basic.
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- RapidCross — Covidien LP · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 695848140064MH | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- BrosMed Medical Co., Ltd
- EUDAMED SRN
- CN-MF-000007501
- Authorised Representative
- Brosmed Medical B.V. NL-AR-000002616
Sources (2)
- EUDAMED 5ed53492-bc43-45ce-81dc-c27a204c5b0b 61 fields · synced May 29, 2026
- FDA UDI af7f635a-45ef-4b28-a70a-599976a8f810 34 fields · synced May 29, 2026