Identity
- Trade Name
- HandX Needle Holder EUDAMED
- Device Name
- HandX Needle Holder EUDAMED
- Model / Reference
- 20-30-011-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 17290017376063 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 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 bcb6ea96-f064-436d-b508-049eb47e474f 61 fields · synced Jul 25, 2026