Identity
- Trade Name
- Sterile PTA Balloon Catheter EUDAMED
- Device Name
- Sterile PTA Balloon Catheter EUDAMED
- Model / Reference
- H130080006018D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06927741083366 EUDAMED
- Basic UDI-DI
- 69277410ZBT0003TF EUDAMED
- EMDN Code
- C010401020101 PTCA BALLOON DILATION CATHETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Sterile PTA Balloon Catheter by Zhejiang Barty Medical Technology Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69277410ZBT0003TF | Class IIa | Active |
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Manufacturer
- Manufacturer
- Zhejiang Barty Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000007977
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED f987f975-e5b6-48de-b7f6-02b01960e7ae 61 fields · synced Jun 19, 2026