Identity
- Trade Name
- Sterile PTCA Balloon Catheter EUDAMED
- Device Name
- Sterile PTCA Balloon Catheter EUDAMED
- Model / Reference
- PN22520 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06927741078232 EUDAMED
- Basic UDI-DI
- 69277410ZBT0001TB EUDAMED
- EMDN Code
- C010401020101 PTCA BALLOON DILATION CATHETERS EUDAMED
Classification
- Device Class
- Class III 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 PTCA Balloon Catheter by Zhejiang Barty Medical Technology Co., Ltd. — Class III — 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 | 69277410ZBT0001TB | Class III | 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 97b6ae18-600d-4086-a36e-caf6bf4e1502 61 fields · synced Jun 17, 2026