← Back to catalogue
INSIGHT Lateral Access Light
EUDAMEDClass IIa (EU MDR)
Ref 03.816.700Model INSIGHT Lateral Access Reusable LightRef 03.816.710SModel INSIGHT Lateral Access Disposable Light
by Synthes GmbH
Identity
- Device Name
- INSIGHT Lateral Access Light EUDAMEDINSIGHT Lateral Access Light Clip EUDAMED
- Model / Reference
- INSIGHT Lateral Access Reusable Light EUDAMED03.816.700 EUDAMEDINSIGHT Lateral Access Disposable Light EUDAMED03.816.710S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07611819583894 EUDAMED07611819529441 EUDAMED
- Basic UDI-DI
- 7611819a00446JU EUDAMED7611819a00451JM EUDAMED
- Direct Marketing DI
- 07611819583894 EUDAMED
- EMDN Code
- Z12139099 VARIOUS ORTHOPAEDIC AND TRAUMATOLOGY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMEDEUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMEDEUDAMED
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 guidewire, reusable
INSIGHT Lateral Access Light by Synthes GmbH — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic guidewire, reusable.
- Guide Wire — I.T.S. GmbH · Class I
- Parallel Wire Guide, for φ2.5 Guide Wire, Adjustable — Double Medical Technology Inc. · Class II
- Guidewire, Nitinol, Double Blunt, 1.19 x 610mm — Captiva Spine · Class I
- Cosmolock — Kalitec Direct LLC · Class I
- Minuteman — Spinal Simplicity, LLC · Class I
- OPTILOCK PERIARTICULAR PLATING SYSTEM — Biomet Orthopedics, Inc. · Class II
- Dyna Locking Trochanteric Nail — CG MedTech Co., Ltd. · Class I
- Made-To-Order — WRIGHT MEDICAL TECHNOLOGY, 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 | 7611819a00446JU | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Synthes GmbH
- EUDAMED SRN
- CH-MF-000013345
- Authorised Representative
- DePuy Ireland UC IE-AR-000009328
Sources (2)
- EUDAMED 6465abfc-fc87-450f-addc-9b57204e1f7b 61 fields · synced Jul 25, 2026
- EUDAMED dfa616df-a884-43fd-a2a0-2dbeebc746fe 61 fields · synced May 19, 2026