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Sv130
EUDAMEDClass IIa (EU MDR)
Ref SV130Model 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 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
- 06936260803034 EUDAMED
- Basic UDI-DI
- B-06936260803034 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 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-06936260803034 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06936260803034 | 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 15d0daf5-b0c2-4b63-90c3-3f1325c8c950 61 fields · synced Jul 13, 2026
- EUDAMED 9271a241-551c-4bde-9825-625ec3731a8a 61 fields · synced Jul 9, 2026