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AVANTEON® Broach - Size 0, 45mm Offset - Sequential 1mm
EUDAMEDClass I (EU MDR)
Ref 007515
Identity
- Trade Name
- AVANTEON® Broach - Size 0, 45mm Offset - Sequential 1mm EUDAMED
- Device Name
- Orthopaedic Surgery Rasps EUDAMED
- Model / Reference
- 007515 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05032982064744 EUDAMED
- Basic UDI-DI
- 5032982/INSLRASP01/T5 EUDAMED
- EMDN Code
- L091201 ORTHOPAEDIC SURGERY RASPS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
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
AVANTEON® Broach - Size 0, 45mm Offset - Sequential 1mm by JRI Orthopaedics Ltd — 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 | 5032982/INSLRASP01/T5 | Class I | Active |
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Manufacturer
- Manufacturer
- JRI Orthopaedics Ltd
- EUDAMED SRN
- GB-MF-000007529
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED a7882f80-0e4a-46ac-b280-befd485d11b4 61 fields · synced Jul 13, 2026