Identity
- Trade Name
- Hydrus EUDAMED
- Device Name
- Balloon Dilatation Catheter EUDAMED
- Model / Reference
- PB-120-040-150 EUDAMED02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970757207325 EUDAMED
- Basic UDI-DI
- B-06970757207325 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
Hydrus 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-06970757207325 | 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 aa65c42f-4fb6-4786-b02b-ea0f57c413a0 61 fields · synced Oct 5, 2026