Minerva PTA Balloon Dilatation Catheter
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- Minerva EUDAMEDMinerva PTA Balloon Dilatation Catheter FDA UDI
- Generic Name
- Peripheral angioplasty balloon catheter, basic FDA UDI
- Device Name
- Minerva PTA Balloon Dilatation Catheter EUDAMEDMinerva / Xpansion PTA Balloon Dilatation Catheter EUDAMED
- Model / Reference
- 803-040060-070 EUDAMEDrev 01 FDA UDI
Identifiers
- Catalog Number
- 803-040060-070U FDA UDI
- Primary DI / UDI-DI
- 06958481414677 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06958481414677 EUDAMED695848140013LY 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
Minerva PTA Balloon Dilatation Catheter by BrosMed Medical Co., Ltd. — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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
CE/MDD
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06958481414677 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | B-06958481414677 | 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 fb7c70e7-7616-4942-9a68-2e7ae658fcba 61 fields · synced Jul 26, 2026
- EUDAMED 09b95f57-d9fd-46fa-83b9-d5344d2b2416 61 fields · synced May 17, 2026
- FDA UDI 7b1ecec5-db8b-4954-8267-adae0263a5a3 33 fields · synced May 26, 2026