← Back to catalogue
Zeramex Docklocs® Latch Handpiece Driver, Tri-Lobe (with Abutment Holder Sleeve)
EUDAMEDClass IIa (EU MDR)
Ref XT38227Model Instrument
Identity
- Trade Name
- Zeramex Docklocs® Latch Handpiece Driver, Tri-Lobe (with Abutment Holder Sleeve) EUDAMED
- Model / Reference
- Instrument EUDAMEDXT38227 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +EMESXT382270 EUDAMED
- Basic UDI-DI
- ++EMESG00326 EUDAMED
- EMDN Code
- L26 SURGICAL SCREWDRIVERS, REUSABLE 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
Category: Surgical screwdriver, reusable
Zeramex Docklocs® Latch Handpiece Driver, Tri-Lobe (with Abutment Holder Sleeve) by MEDEALIS GmbH — Class IIa — MDR — listed in EUDAMED
Similar devices
Also classified as Surgical screwdriver, reusable.
- Fortex Pedicle Screw System — Xtant Medical Holdings, Inc. · Class II
- MEGA PLUS SPINE SYSTEM — BK MEDITECH CO., LTD. · Class I
- Inclusive — PRISMATIK DENTALCRAFT, INC. · Class I
- LOSPA IS Spinal Fixation System — Corentec Co., Ltd · Class II
- PERLA ® TL — Spineart · Class II
- USS — Synthes · Class I
- Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class I
- CosmoLock Pedicle Screw System — Kalitec Direct LLC · Class I
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 | ++EMESG00326 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- MEDEALIS GmbH
- EUDAMED SRN
- DE-MF-000019555
Sources (1)
- EUDAMED 1d218eee-c84f-4e8b-a8ce-3990c28ba647 61 fields · synced Jul 28, 2026