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Sagittal Alignment Connector - Pivot with Fan
EUDAMEDClass I (EU MDR)
Ref 4240-7706
Identity
- Trade Name
- Sagittal Alignment Connector - Pivot with Fan EUDAMED
- Device Name
- Knee Replacement Instruments EUDAMED
- Model / Reference
- 4240-7706 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09421038411919 EUDAMED
- Basic UDI-DI
- 942102811GMN004025 EUDAMED
- Direct Marketing DI
- 09421038411919 EUDAMED
- EMDN Code
- L0922 ORTHOPAEDIC SURGERY GUIDES, 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
Sagittal Alignment Connector - Pivot with Fan 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 | 942102811GMN004025 | 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 d2a921a7-45b5-45da-8316-6dc8cbf8dd54 61 fields · synced Jul 9, 2026