Identity
- Trade Name
- Graft Preparation Tool - 55mm EUDAMED
- Device Name
- Ligament Tensioner - Non-measuring EUDAMED
- Model / Reference
- 35130805 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09421028118132 EUDAMED
- Basic UDI-DI
- 942102811GMN00172A EUDAMED
- Direct Marketing DI
- 09421028118132 EUDAMED
- EMDN Code
- L091106 INSTRUMENTS FOR THE PREPARATION OF TISSUE IMPLANTS IN ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY, REUSABLE EUDAMED
Classification
- Device Class
- Class I 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
Graft Preparation Tool - 55mm by Enztec Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 942102811GMN00172A | Class I | Active |
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Manufacturer
- Manufacturer
- Enztec Limited
- EUDAMED SRN
- NZ-MF-000002264
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED efff1f41-23d5-4977-999b-dc0a5798ead9 61 fields · synced Jul 15, 2026