← Back to catalogue
Balloon Dilatation Catheter
EUDAMEDClass IIa (EU MDR)
Ref 02Model PA-040-020-090
Identity
- Device Name
- Balloon Dilatation Catheter EUDAMED
- Model / Reference
- PA-040-020-090 EUDAMED02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970757207486 EUDAMED
- Basic UDI-DI
- B-06970757207486 EUDAMED
- EMDN Code
- C01050299 INTRAVASCULAR EMBOLIC PROTECTION CATHETERS AND SYSTEMS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Balloon Dilatation Catheter by Skynor Medical（Shanghai）Co., Ltd — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06970757207486 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Skynor Medical（Shanghai）Co., Ltd
- EUDAMED SRN
- CN-MF-000028227
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (1)
- EUDAMED 9adda48d-e320-499e-9905-49b6abb9e48f 61 fields · synced Jun 18, 2026