← Back to catalogue
Atropos PTA Balloon Dilatation Catheter
EUDAMEDClass IIa (EU MDR)
Ref 819-070040-040
Identity
- Trade Name
- Atropos EUDAMED
- Device Name
- Atropos PTA Balloon Dilatation Catheter EUDAMEDAtropos / Xpansion AVF PTA Balloon Dilatation Catheter EUDAMED
- Model / Reference
- 819-070040-040 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06958481460193 EUDAMED
- Basic UDI-DI
- B-06958481460193 EUDAMED695848140015M4 EUDAMED
- EMDN Code
- C010402020101 PTA BALLOON DILATATION CATHETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Peripheral angioplasty balloon catheter, basic
Atropos PTA Balloon Dilatation Catheter by BrosMed Medical Co., Ltd. — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Peripheral angioplasty balloon catheter, basic.
- Advocate™ — Merit Medical Systems, Inc. · Class II
- Senri — KANEKA Corporation · Class IIa
- Jade PTA Balloon Dilatation Catheter — OrbusNeich Medical (ShenZhen) Co., Ltd. · Class II
- ZENFluxion — Zylox-Tonbridge Medical Technology Co., Ltd. · Class III
- Pacific™ Plus — MEDTRONIC, INC. · Class II
- Metacross OTW — KANEKA Corporation · Class IIa
- Armada — Abbott Vascular · Class II
- RapidCross — Covidien LP · Class II
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06958481460193 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06958481460193 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- BrosMed Medical Co., Ltd
- EUDAMED SRN
- CN-MF-000007501
- Authorised Representative
- Brosmed Medical B.V. NL-AR-000002616
Sources (2)
- EUDAMED b27e3800-aec5-4a1b-b2d3-388ece55af16 61 fields · synced Jul 19, 2026
- EUDAMED 2c42fc9c-bd72-4527-a5df-ee2f00b1a2b8 61 fields · synced May 18, 2026