Identity
- Trade Name
- HandX Handpiece EUDAMED
- Device Name
- HandX Handpiece EUDAMED
- Model / Reference
- 20-30-017-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 17290017376049 EUDAMED
- Basic UDI-DI
- 07290017376HXP003WL EUDAMED
- EMDN Code
- K0108 HAND-ASSISTED SURGERY DEVICES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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 Handpiece 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 | 07290017376HXP003WL | 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 8d37ccdb-eaff-438a-a38d-e129df6ebe46 61 fields · synced Jun 18, 2026