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HandX Self- righting Needle Holder
EUDAMEDClass IIa (EU MDR)
Ref 20-30-078-02Model 20-30-011-02
Identity
- Trade Name
- HandX Self- righting Needle Holder EUDAMED
- Device Name
- HandX Needle Holder EUDAMED
- Model / Reference
- 20-30-011-02 EUDAMED20-30-078-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290017376233 EUDAMED
- Basic UDI-DI
- 07290017376HXP001WG EUDAMED
- EMDN Code
- K01020105 MINIMALLY INVASIVE SURGERY NEEDLE HOLDERS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
HandX Self- righting Needle Holder by HumanTouch Surgical 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 | 07290017376HXP001WG | Class IIa | Active |
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Manufacturer
- Manufacturer
- HumanTouch Surgical LTD.
- EUDAMED SRN
- IL-MF-000009116
- Authorised Representative
- MedNet EC-REP IIb GmbH DE-AR-000011192
Sources (1)
- EUDAMED c4986260-2fd4-428e-b0af-5a6d7b5435ba 61 fields · synced Jun 18, 2026