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Percutaneous Access Needle
EUDAMEDClass IIa (EU MDR)
Ref SV510-2401Model SV510-3001, SV510-4201, SV510-2401, SV510-3601
Identity
- Device Name
- Percutaneous Access Needle EUDAMED
- Model / Reference
- SV510-3001, SV510-4201, SV510-2401, SV510-3601 EUDAMEDSV510-2401 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936260814092 EUDAMED
- Basic UDI-DI
- 69362608SV510-01Q2 EUDAMED
- EMDN Code
- P099002 ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
Percutaneous Access Needle by Hicren (Zhejiang) Medtech Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69362608SV510-01Q2 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hicren (Zhejiang) Medtech Co., Ltd.
- EUDAMED SRN
- CN-MF-000025999
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED 0af850a3-43b4-49c2-8caa-00c37fa63c85 61 fields · synced Jul 25, 2026