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Sv110-2019
EUDAMEDClass IIa (EU MDR)
Ref SV110-2019Model SV110-3010, SV110-3013, SV110-3712, SV110-4213, SV110-2019, SV110-2818, SV110-3519, SV110-3912
Identity
- Device Name
- Percutaneous Access Needle EUDAMED
- Model / Reference
- SV110-2019 EUDAMEDSV110-3010, SV110-3013, SV110-3712, SV110-4213, SV110-2019, SV110-2818, SV110-3519, SV110-3912 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936260801054 EUDAMED
- Basic UDI-DI
- B-06936260801054 EUDAMED69362608SV110-01NE 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
Sv110-2019 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-06936260801054 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06936260801054 | 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 8e1eabb1-a407-4541-b3bb-dbf8c224ab13 61 fields · synced Jul 15, 2026
- EUDAMED f4322081-c8b0-476a-ae34-991a3ded15ad 61 fields · synced Jun 11, 2026