Identity
- Device Name
- Reusable Instrumentation EUDAMED
- Model / Reference
- 770001151A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00196449017348 EUDAMED
- Basic UDI-DI
- 081991702011AS EUDAMED
- EMDN Code
- L26 SURGICAL SCREWDRIVERS, REUSABLE EUDAMED
Classification
- Device Class
- Class I 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
Reusable Instrumentation by Tyber Medical — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 081991702011AS | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Tyber Medical
- EUDAMED SRN
- US-MF-000011350
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 6bb606ad-0396-4276-88da-5644a2260042 61 fields · synced Jun 18, 2026