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Bone Cement Mixing Set
EUDAMEDClass I (EU MDR)
Ref SV120-05Model SV120-03, SV120-0301, SV120-0302, SV120-04, SV120-0401, SV120-0402, SV120-05, SV120-0501, SV120-0502
Identity
- Device Name
- Bone Cement Mixing Set EUDAMED
- Model / Reference
- SV120-03, SV120-0301, SV120-0302, SV120-04, SV120-0401, SV120-0402, SV120-05, SV120-0501, SV120-0502 EUDAMEDSV120-05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936260855255 EUDAMED
- Basic UDI-DI
- 69362608SV120-002TX 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 | 69362608SV120-002TX | 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 f1f5a3ad-3796-4d48-85f5-b2d8589d2335 61 fields · synced Jul 28, 2026