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Hds-122 - Hekadrill Handpiece - Electric, Lever
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref HDS-122
by Zethon Ltd
Identity
- Device Name
- HDS-122 - HEKADRILL HANDPIECE - ELECTRIC, LEVER EUDAMED
- Model / Reference
- HDS-122 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05059358044605 EUDAMED
- Basic UDI-DI
- B-05059358044605 EUDAMED
- EMDN Code
- Z12100902 DRILLS FOR NEUROSURGERY EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Hds-122 - Hekadrill Handpiece - Electric, Lever by Zethon Ltd — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K233958 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K193630 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-05059358044605 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Zethon Ltd
- EUDAMED SRN
- GB-MF-000014309
- Authorised Representative
- De Soutter Medical Limited NL-AR-000000438
Sources (2)
- EUDAMED ed126d26-ed32-4c38-aa74-3fa825db1352 61 fields · synced Jun 20, 2026
- FDA 510(k) K233958 1 fields · synced May 18, 2026