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Sv120-02
EUDAMEDClass IIa (EU MDR)
Ref SV120-02Model SV120-01, SV120-0101, SV120-0102, SV120-02, SV120-0201, SV120-0202
Identity
- Device Name
- Bone Cement Mixing Set EUDAMED
- Model / Reference
- SV120-02 EUDAMEDSV120-01, SV120-0101, SV120-0102, SV120-02, SV120-0201, SV120-0202 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936260803089 EUDAMED
- Basic UDI-DI
- B-06936260803089 EUDAMED69362608SV120-001TV 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
Sv120-02 by Ningbo HicRen Biotechnology 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-06936260803089 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06936260803089 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ningbo HicRen Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000025999
- Authorised Representative
- Llins Service & Consulting GmbH DE-AR-000009077
Sources (2)
- EUDAMED b2c61c83-b022-4f50-947f-3357edb8362a 61 fields · synced Jul 30, 2026
- EUDAMED 0c8dffed-aa39-479c-a274-7c29ed764e68 61 fields · synced Jul 30, 2026