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Balloon Catheter
EUDAMEDClass IIa (EU MDR)
Ref SV211-14Model SV211-14, SV211-18, SV211-22, SV211-26, SV211-14S, SV211-18S, SV211-22S, SV211-26S, SV211-15Z, SV211-18Z, SV211-22Z, SV211-27Z, SV211-15SZ, SV211-18SZ, SV211-22SZ, SV211-27SZ
Identity
- Device Name
- Balloon Catheter EUDAMED
- Model / Reference
- SV211-14, SV211-18, SV211-22, SV211-26, SV211-14S, SV211-18S, SV211-22S, SV211-26S, SV211-15Z, SV211-18Z, SV211-22Z, SV211-27Z, SV211-15SZ, SV211-18SZ, SV211-22SZ, SV211-27SZ EUDAMEDSV211-14 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936260855460 EUDAMED
- Basic UDI-DI
- 69362608SV211S2 EUDAMED
- EMDN Code
- P099002 ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
Balloon Catheter by Hicren (Zhejiang) Medtech 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 | 69362608SV211S2 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hicren (Zhejiang) Medtech Co., Ltd.
- EUDAMED SRN
- CN-MF-000025999
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED ef052ad0-1d30-4546-8985-5ffc689c973d 61 fields · synced Jul 25, 2026