← Back to catalogue
Mountaineer Oct Spinal System
EUDAMEDClass IIb (EU MDR)
Ref 188363200SModel MOUNTAINEER OCT SYSTEM OC RODS
Identity
- Trade Name
- MOUNTAINEER OCT SPINAL SYSTEM EUDAMED
- Device Name
- RODS FOR CERVICAL FIXATION SYSTEM EUDAMED
- Model / Reference
- MOUNTAINEER OCT SYSTEM OC RODS EUDAMED188363200S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10705034422398 EUDAMED
- Basic UDI-DI
- 0705034a002435Y EUDAMED
- EMDN Code
- P09070301 CERVICAL FIXATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
Yes
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: Cervical spine immobilization system, single-use
Mountaineer Oct Spinal System by Medos International Sarl — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Cervical spine immobilization system, single-use.
- Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
- PMT® Halo Systems — Pmt Corp. · Class II
- PMT® Halo Systems — Pmt Corp. · Class II
- MATRIS - Cervical plates and screw — NovaSpine · Class IIb
- PMT® Halo Systems — Pmt Corp. · Class II
- PCF Rod — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
- TST Spinal System — TST RAKOR VE TIBBİ ALETLER SAN.VE TİC.LTD.ŞTİ. · Class IIb
- PMT® Halo Systems — Pmt Corp. · Class II
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 | 0705034a002435Y | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medos International SARL
- EUDAMED SRN
- CH-MF-000014268
- Authorised Representative
- DePuy Ireland UC IE-AR-000009328
Sources (1)
- EUDAMED 61ed6ad5-19d5-449d-b941-f2d0e8c18c30 61 fields · synced Jun 18, 2026