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Std-0080
EUDAMEDClass IIa (EU MDR)
Ref STD-0080Model Connected to active device - Knee
Identity
- Model / Reference
- Connected to active device - Knee EUDAMEDSTD-0080 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03700535128817 EUDAMED
- Basic UDI-DI
- 3700535100053Q2 EUDAMED
- EMDN Code
- L091102 ORTHOPAEDIC PROSTHESES REAMERS AND BURS, REUSABLE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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: Acetabular orthopaedic reamer
Std-0080 by X.nov Medical Technology — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 3700535100053Q2 | Class IIa | Active |
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Manufacturer
- Manufacturer
- X.nov Medical Technology
- EUDAMED SRN
- CH-MF-000018319
- Authorised Representative
- X.NOV FR-AR-000007682
Sources (1)
- EUDAMED 52cfb0f7-5a22-49e0-9c12-9d617533d98a 61 fields · synced Jul 24, 2026