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D-Reamer
EUDAMEDClass IIa (EU MDR)
Ref RM35Ref RM14Ref RM13Ref RM21Ref RM23Ref RM27Ref RM18Ref RM22Ref RM17Ref RM31Ref RM19Ref RM30Ref RM10
Identity
- Device Name
- D-Reamer EUDAMED
- Model / Reference
- RM35 EUDAMEDRM14 EUDAMEDRM13 EUDAMEDRM21 EUDAMEDRM23 EUDAMEDRM27 EUDAMEDRM18 EUDAMEDRM22 EUDAMEDRM17 EUDAMEDRM31 EUDAMEDRM19 EUDAMEDRM30 EUDAMEDRM10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640168630355 EUDAMED07640168630140 EUDAMED07640168630133 EUDAMED07640168630218 EUDAMED07640168630232 EUDAMED07640168630270 EUDAMED07640168630188 EUDAMED07640168630225 EUDAMED07640168630171 EUDAMED07640168630317 EUDAMED07640168630195 EUDAMED07640168630300 EUDAMED07640168630102 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
Category: Acetabular orthopaedic reamer
D-Reamer by QuantièmePlus SA — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 (13)
- EUDAMED 1a212ca2-d747-4ec9-8cb9-9f32e947f79f 61 fields · synced Aug 4, 2026
- EUDAMED 959b8e5e-395b-4519-a099-b0ab8327f6e9 61 fields · synced May 16, 2026
- EUDAMED 6d860d4c-1486-4d09-91f6-68723efd9f4b 61 fields · synced May 17, 2026
- EUDAMED 6581397e-d1bd-4467-a79f-a4c0c19878c0 61 fields · synced May 17, 2026
- EUDAMED 20f9cf71-62c9-461d-8d1d-8b02b815b2a4 61 fields · synced May 17, 2026
- EUDAMED 7992d64f-33b9-49ca-8ee6-b2636022f9d8 61 fields · synced May 18, 2026
- EUDAMED a4b28365-18d8-4fc0-8f88-9bc7acd0b88f 61 fields · synced May 18, 2026
- EUDAMED 422e76ef-baf3-4c87-b778-4ef34cd22c67 61 fields · synced May 18, 2026
- EUDAMED 3a3928d3-41c6-4009-ae72-7872ba8a53ec 61 fields · synced May 18, 2026
- EUDAMED 3cf9e282-6170-48cb-b550-f045f8e04dbb 61 fields · synced May 19, 2026
- EUDAMED 4eef100f-9477-4e25-816d-ae0a221a9a85 61 fields · synced May 19, 2026
- EUDAMED 750537f0-46fa-4e95-a20c-280911f818a1 61 fields · synced May 19, 2026
- EUDAMED 2fc665c1-1609-49fe-ba20-e0fb35843724 61 fields · synced May 19, 2026