Polux PTA Balloon Dilatation Catheter
EUDAMEDFDA UDIClass IIa (EU MDR)
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
- 818-050040-090 EUDAMEDrev 01 FDA UDI
Identifiers
- Catalog Number
- 818-050040-090U FDA UDI
- Primary DI / UDI-DI
- 06958481444308 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06958481444308 EUDAMED695848140011LU 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
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Peripheral angioplasty balloon catheter, basic
Polux PTA Balloon Dilatation Catheter by BrosMed Medical Co., Ltd. — Class IIa — MDR, MDD, 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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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06958481444308 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06958481444308 | 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 47c44c3f-3cfd-4e9a-bc58-a77c7c32078d 61 fields · synced Jul 19, 2026
- EUDAMED dd0a398d-3ff1-4b63-9a6b-433467432aae 61 fields · synced May 16, 2026
- FDA UDI a0e26331-4232-48aa-886e-4de5b841717a 33 fields · synced May 30, 2026