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Mountaineer 188365000

by Medos International Sàrl

Ref 188365000

Mountaineer 188365000 is a device classified as Class IIb in the EU and Class II in the US made by Medos International Sàrl, registered in EUDAMED on 3 Nov 2026 (Basic UDI-DI B-CHMF000014268000349Z4), cleared under FDA 510(k) K190895 on 18 Jul 2019 (2 earlier submissions) and listed in FDA GUDID since 24 Sep 2015 (UDI-DI D-CHMF000014268000349Z4), active as of 7 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K190895

+2 more

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-CHMF000014268000349Z4 Basic UDI-DI D-CHMF000014268000349Z4UDI-DIDate3 Nov 2026RegisteredStatusActive
United StatesFDA 510(k) GUDID from GUDID NumberK190895 Date18 Jul 2019IssuedStatusActive
United StatesGUDID listing GUDID NumberD-CHMF000014268000349Z4 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-CHMF000014268000349Z4 registered 3 Nov 2026 Active
  • FDA 510(k) K190895 decided 18 Jul 2019 Active· +2 more in the status table
  • FDA GUDID UDI-DI D-CHMF000014268000349Z4 listed 24 Sep 2015 Listed

Timeline

5 dated events

  1. Cleared FDA 510(k) K042508
  2. Cleared FDA 510(k) K151885
  3. Listed FDA GUDID D-CHMF000014268000349Z4
  4. Cleared FDA 510(k) K190895
  5. Registered EUDAMED B-CHMF000014268000349Z4

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Mountaineer
Generic name
Implantable bone washer
Model / Ref / Catalog
188365000
Primary DI / UDI-DI
D-CHMF000014268000349Z4 EUDAMED
10705034159089 GUDID
Basic UDI-DI
B-CHMF000014268000349Z4
510(k) Number
FDA product code
KWP, MNI, NKG
EMDN code
P09070301 Cervical fixation systems
GMDN term
Implantable bone washer
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3050, 888.3070, 888.3075
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
D-CHMF000014268000349Z4
GUDID
10705034159089
Device classEUDAMED
Class IIb
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists D-CHMF000014268000349Z4; FDA GUDID lists 10705034159089), so their flags are not compared. Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Implantable bone washer

Cleared under the same submission (K042508)

Cleared under the same submission (K151885)

and 1 more cleared under K151885

Similar devices in this category

Other devices filed under CERVICAL FIXATION SYSTEMS.

Other devices from Medos International SARL

See all devices from Medos International SARL →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
Other properties (20, all answered No)