← Back to catalogue
Nitinol Flexible Reamer - 8.5mm (Monobloc)
EUDAMEDClass I (EU MDR)
Ref 210-01-085
Identity
- Trade Name
- Nitinol Flexible Reamer - 8.5mm (Monobloc) EUDAMED
- Device Name
- Non-active Cutting Instruments EUDAMED
- Model / Reference
- 210-01-085 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05032982034266 EUDAMED
- Basic UDI-DI
- 5032982/INSCUTNOTACT/B6 EUDAMED
- EMDN Code
- L091102 ORTHOPAEDIC PROSTHESES REAMERS AND BURS, 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
Nitinol Flexible Reamer - 8.5mm (Monobloc) 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/INSCUTNOTACT/B6 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- JRI Orthopaedics Ltd
- EUDAMED SRN
- GB-MF-000007529
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 6ffc7e45-687e-4d04-ad14-76b84ff40cb3 61 fields · synced Jul 10, 2026