Identity
- Device Name
- D-Reamer EUDAMED
- Model / Reference
- RM28 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640168630287 EUDAMED
- Basic UDI-DI
- 764016863REUTJS 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
D-Reamer by QuantièmePlus SA — Class IIa — 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 | 764016863REUTJS | Class IIa | Active |
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Manufacturer
- Manufacturer
- QuantièmePlus SA
- EUDAMED SRN
- CH-MF-000011186
- Authorised Representative
- LAPE Médical FR-AR-000007694
Sources (1)
- EUDAMED d8a6df6e-c12a-45d6-ab15-75cddc8ec13e 61 fields · synced Jun 19, 2026