Identity
- Trade Name
- Sterile PTA Balloon Catheter EUDAMED
- Device Name
- Sterile PTA Balloon Catheter EUDAMED
- Model / Reference
- H130020006018D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06927741083281 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
Category: Coronary angioplasty balloon catheter, cutting/scoring
Sterile PTA Balloon Catheter by Zhejiang Barty Medical Technology Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Coronary angioplasty balloon catheter, cutting/scoring.
- Pipit SC — Sahajanand Medical Technologies Limited · Class III
- Kulani™ NC — Meril Life Sciences Pvt. Ltd. · Class III
- Invader PTCA — Alvimedica Tibbi Urunler San. ve Dis Tic. A.S. · Class III
- Wolverine Coronary Cutting Balloon — Boston Scientific · Class III
- Pipit SC — Sahajanand Medical Technologies Limited · Class III
- POT — BrosMed Medical Co., Ltd. · Class III
- Simpass — Simeks Tibbi Urunler San. ve Tic LTD STI · Class III
- JUTURNA-c PTCA Balloon Catheter — QualiMed Innovative Medizinprodukte GmbH · Class III
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zhejiang Barty Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000007977
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 58e7504a-c3ee-47cb-be0f-29bf53f64491 61 fields · synced Jun 19, 2026