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Hds-111 - Hekadrill Handpiece - Air/Nitrogen
EUDAMEDClass IIa (EU MDR)
Ref HDS-111
by Zethon Ltd
Identity
- Device Name
- HDS-111 - HEKADRILL HANDPIECE - AIR/NITROGEN EUDAMED
- Model / Reference
- HDS-111 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060528013369 EUDAMED
- Basic UDI-DI
- B-05060528013369 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-111 - Hekadrill Handpiece - Air/Nitrogen by Zethon Ltd — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05060528013369 | 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 (1)
- EUDAMED 3073dd26-057d-4527-a5db-28d441e100d2 61 fields · synced Jun 19, 2026