Identity
- Trade Name
- Double Angled Gouge - 9mm Wide Blade EUDAMED
- Device Name
- Orthopaedic Surgery Gouges EUDAMED
- Model / Reference
- 10-09-15 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05032982001862 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
- Portugal 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
Double Angled Gouge - 9mm 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 a129e9c3-f4d1-4719-9ad3-4866f5fbd9c8 61 fields · synced Jun 18, 2026