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Bone Cement Mixing Set
EUDAMEDClass I (EU MDR)
Ref SV120-11Model SV120-09, SV120-0901, SV120-0902, SV120-10, SV120-1001, SV120-1002, SV120-11, SV120-1101, SV120-1102
Identity
- Device Name
- Bone Cement Mixing Set EUDAMED
- Model / Reference
- SV120-09, SV120-0901, SV120-0902, SV120-10, SV120-1001, SV120-1002, SV120-11, SV120-1101, SV120-1102 EUDAMEDSV120-11 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936260855439 EUDAMED
- Basic UDI-DI
- 69362608SV120-004U3 EUDAMED
- EMDN Code
- P099002 ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS EUDAMED
Classification
- Device Class
- Class I 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
Bone Cement Mixing Set by Hicren (Zhejiang) Medtech Co., Ltd. — Class I — 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 | 69362608SV120-004U3 | Class I | 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 f3519c3c-d3fd-42c7-9eb1-7e3e940c595f 61 fields · synced Jul 25, 2026