Identity
- Device Name
- ReamerPlus EUDAMED
- Model / Reference
- ReamerPlus EUDAMEDRM03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640168630034 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 (1)
- EUDAMED b61561f8-a93a-4303-9961-a5f3575d0658 61 fields · synced Jun 19, 2026