Identity
- Trade Name
- Activa Instrument EUDAMEDHEX shaft, for 4.5mm screws EUDAMED
- Device Name
- HEX shaft, for 4.5mm screws EUDAMEDHex Driver EUDAMED
- Model / Reference
- B-IS-9033 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438394003354 EUDAMED
- Basic UDI-DI
- B-06438394003354 EUDAMED6438394INS012WK EUDAMED
- Direct Marketing DI
- 06438394003354 EUDAMED
- EMDN Code
- L26 SURGICAL SCREWDRIVERS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Finland 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
Activa Instrument by Bioretec Ltd. — Class I — MDR, MDD — 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
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06438394003354 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06438394003354 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bioretec Ltd.
- EUDAMED SRN
- FI-MF-000001328
Sources (2)
- EUDAMED 760186eb-03e2-4587-9bdf-475742fb5bc4 61 fields · synced Aug 3, 2026
- EUDAMED 903ec063-b001-438b-b3f7-baa45631cf2f 61 fields · synced May 18, 2026