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Mountaineer Oct Spinal System

EUDAMED

Class IIb (EU MDR)

Ref 188363200SModel ‌MOUNTAINEER OCT SYSTEM OC RODS

by Medos International SARL

Identity

Trade Name
MOUNTAINEER OCT SPINAL SYSTEM EUDAMED
Device Name
‌RODS FOR CERVICAL FIXATION SYSTEM EUDAMED
Model / Reference
‌MOUNTAINEER OCT SYSTEM OC RODS EUDAMED
188363200S 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.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

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