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Achilles PTA Balloon Dilatation Catheter
EUDAMEDClass IIa (EU MDR)
Ref 804-050020-040
Identity
- Trade Name
- Achilles EUDAMED
- Device Name
- Achilles PTA Balloon Dilatation Catheter EUDAMED
- Model / Reference
- 804-050020-040 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06958481458176 EUDAMED
- Basic UDI-DI
- B-06958481458176 EUDAMED695848140014M2 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
Achilles PTA Balloon Dilatation Catheter by BrosMed Medical Co., Ltd. — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Peripheral angioplasty balloon catheter, basic.
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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-06958481458176 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06958481458176 | Class IIa | Active |
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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 df39a48b-f27f-45dd-8c21-1e285daab296 61 fields · synced May 24, 2026
- EUDAMED 7c65a7a7-63ad-4a8d-a487-f2f5fe0e89f7 61 fields · synced May 18, 2026