← Back to catalogue
Broche 2 Bouts Mousse Ø2.0l350
EUDAMEDClass IIa (EU MDR)
Ref OAIMM235Model Orthopaedic implant instruments, single use - other
Identity
- Trade Name
- BROCHE 2 BOUTS MOUSSE Ø2.0L350 EUDAMED
- Device Name
- Orthopaedic implant instruments, single use - other EUDAMED
- Model / Reference
- Orthopaedic implant instruments, single use - other EUDAMEDOAIMM235 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +M483OAIMM2350 EUDAMED
- Basic UDI-DI
- ++M483P091399JU EUDAMED
- Direct Marketing DI
- +M483OAIMM2350 EUDAMED
- EMDN Code
- P091399 ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
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
Category: Joint prosthesis implantation kit, single-use
Broche 2 Bouts Mousse Ø2.0l350 by groupe lépine — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Joint prosthesis implantation kit, single-use.
- OvertureTi — OVERTURE ORTHOPAEDICS
- Identity Imprint Knee Replacement System — Conformis, Inc. · Class II
- Dekalb Knee Pack — PACKROOM LLC
- IDENTITY IMPRINT — Conformis, Inc. · Class II
- Argo Knotless — Conmed Corporation · Class IIa
- Instruments IIa — Newclip Technics SAS · Class IIa
- Identity Imprint Knee Replacement System — Conformis, Inc. · Class II
- CC-Hook Right — Xiros Limited · Class IIa
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 | ++M483P091399JU | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- groupe lépine
- EUDAMED SRN
- FR-MF-000001182
Sources (1)
- EUDAMED 9b991907-abe6-4632-9e89-99c11e6fb487 61 fields · synced Jul 12, 2026