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Sv130-3518
EUDAMEDClass IIa (EU MDR)
Ref SV130-3518Model SV130, SV130-281801, SV130-281802, SV130-2814, SV130-281401, SV130-281402, SV130-3518, SV130-351801, SV130-351802, SV130-3514, SV130-351401, SV130-351402
Identity
- Device Name
- Bone Cement Delivery Cannula EUDAMED
- Model / Reference
- SV130-3518 EUDAMEDSV130, SV130-281801, SV130-281802, SV130-2814, SV130-281401, SV130-281402, SV130-3518, SV130-351801, SV130-351802, SV130-3514, SV130-351401, SV130-351402 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936260803249 EUDAMED
- Basic UDI-DI
- B-06936260803249 EUDAMED69362608SV130RZ EUDAMED
- EMDN Code
- P099002 ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMEDSpain 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
Sv130-3518 by Hicren (Zhejiang) Medtech Co., Ltd. — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06936260803249 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06936260803249 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hicren (Zhejiang) Medtech Co., Ltd.
- EUDAMED SRN
- CN-MF-000025999
- Authorised Representative
- Llins Service & Consulting GmbH DE-AR-000009077
Sources (2)
- EUDAMED bfcf9b0a-b625-48d0-830d-8d19b3e5f2ae 61 fields · synced Jul 29, 2026
- EUDAMED 8ef4de9a-6c76-40a7-b0b2-a12a34527927 61 fields · synced Jul 24, 2026