Identity
- Trade Name
- Polux EUDAMEDPolux PTA Balloon Dilatation Catheter FDA UDI
- Generic Name
- Peripheral angioplasty balloon catheter, basic FDA UDI
- Device Name
- Polux PTA Balloon Dilatation Catheter EUDAMED
- Model / Reference
- 818-020015-090 EUDAMEDrev 01 FDA UDI
Identifiers
- Catalog Number
- 818-020015-090U FDA UDI
- Primary DI / UDI-DI
- 06958481441154 EUDAMEDFDA UDI
- Basic UDI-DI
- 695848140011LU EUDAMEDB-06958481441154 EUDAMED
- 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
Polux by BrosMed Medical Co., Ltd. — Class IIa — MDD, 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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- Metacross OTW — KANEKA Corporation · Class IIa
- Armada — Abbott Vascular · Class II
- RapidCross — Covidien LP · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 695848140011LU | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 695848140011LU | 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 (3)
- EUDAMED fdca8d32-d71b-4fdb-837b-9d9cbb971a71 61 fields · synced Jul 10, 2026
- EUDAMED 7e178ff2-3307-4682-b894-3a42c5346923 61 fields · synced May 18, 2026
- FDA UDI 6d4774b9-23f7-49ff-90d4-bce282e01bc8 33 fields · synced May 29, 2026