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New Wave Trial Insert S4 H17
EUDAMEDClass IIa (EU MDR)
Ref GNA SP417Model Orthopaedic prostheses positioners, reusable
Identity
- Trade Name
- NEW WAVE TRIAL INSERT S4 H17 EUDAMED
- Device Name
- Orthopaedic prostheses positioners, reusable EUDAMED
- Model / Reference
- Orthopaedic prostheses positioners, reusable EUDAMEDGNA SP417 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +M483GNASP4170 EUDAMED
- Basic UDI-DI
- ++M483L091104F9 EUDAMED
- Direct Marketing DI
- +M483GNASP4170 EUDAMED
- EMDN Code
- L091104 ORTHOPAEDIC PROSTHESES POSITIONERS, 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: Orthopaedic implant impactor, reusable
New Wave Trial Insert S4 H17 by groupe lépine — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Orthopaedic implant impactor, reusable.
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- Integra® — Ascension Orthopedics, Inc. · Class I
- R3 — Smith & Nephew, Inc. · Class I
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 | ++M483L091104F9 | Class IIa | Active |
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Manufacturer
- Manufacturer
- groupe lépine
- EUDAMED SRN
- FR-MF-000001182
Sources (1)
- EUDAMED b4f9c8f9-44bf-4666-b928-88862e3702f2 61 fields · synced Jun 18, 2026