Identity
- Device Name
- Location Plate EUDAMED
- Model / Reference
- SV150 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936260803041 EUDAMED
- Basic UDI-DI
- B-06936260803041 EUDAMED69362608SV150S7 EUDAMED
- EMDN Code
- P099002 ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass I 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
Sv150 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-06936260803041 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06936260803041 | 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 29314835-d8e5-4d3c-9200-509a46a9391f 61 fields · synced Oct 6, 2026
- EUDAMED b77cc326-3bc4-4e17-9ff0-4f2edcf23e7e 61 fields · synced Jul 26, 2026