Identity
- Device Name
- ReamerPlus EUDAMED
- Model / Reference
- ReamerPlus EUDAMEDRM04 EUDAMEDRM01 EUDAMEDRM02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640168630041 EUDAMED07640168630010 EUDAMED07640168630027 EUDAMED
- Basic UDI-DI
- 764016863DARCDR EUDAMED
- EMDN Code
- P091301 ORTHOPAEDIC IMPLANT REAMERS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
ReamerPlus 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 | 764016863DARCDR | Class IIa | Active |
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Manufacturer
- Manufacturer
- QuantièmePlus SA
- EUDAMED SRN
- CH-MF-000011186
- Authorised Representative
- LAPE Médical FR-AR-000007694
Sources (3)
- EUDAMED 08ad5a86-14bf-41a5-8728-b6aaf3e6cff1 61 fields · synced Jul 10, 2026
- EUDAMED a967dfbc-b331-4d9d-a8fc-2c165f10eaa6 61 fields · synced May 18, 2026
- EUDAMED e55b5007-6768-4ef1-a4d3-b74399ac0055 61 fields · synced May 18, 2026