Identity
- Trade Name
- Swan Necked Gouge - 25mm Wide Blade EUDAMED
- Device Name
- Orthopaedic Surgery Gouges EUDAMED
- Model / Reference
- 14-99-70 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05032982037465 EUDAMED
- Basic UDI-DI
- 5032982/INSLGOU04/Y7 EUDAMED
- EMDN Code
- L090403 ORTHOPAEDIC SURGERY GOUGES, 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
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
Swan Necked Gouge - 25mm Wide Blade 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/INSLGOU04/Y7 | 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 be2728a5-7d70-4820-afb6-bae5f954f0ad 61 fields · synced Jul 23, 2026