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Reusable Instrumentation

by Tyber Medical 114 variants

Part of a family of 128 devices: see the family page

Ref 770017010

Reusable Instrumentation (770017010) is a Class I device made by Tyber Medical, registered in EUDAMED on 12 Mar 2026 (Basic UDI-DI 081991702011AS) and listed in FDA GUDID since 15 Dec 2023 (UDI-DI 00196449012862), active as of 24 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081991702011AS Basic UDI-DI 00196449012862UDI-DIDate12 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00196449012862 UDI-DI Date15 Dec 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081991702011AS registered 12 Mar 2026 Active
  • FDA GUDID UDI-DI 00196449012862 listed 15 Dec 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00196449012862
  2. Registered EUDAMED 081991702011AS

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
A.L.P.S. mvX™
Generic name
Surgical instrument handle, non-torque-limiting
Device name
Reusable Instrumentation
Model / Ref / Catalog
770017010
Primary DI / UDI-DI
00196449012862
Basic UDI-DI
081991702011AS
FDA product code
LXH
EMDN code
L091099 Osteosynthesis instruments, reusable - other
GMDN term
Surgical instrument handle, non-torque-limiting
Device class
Class I
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Sterilise before useEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 00196449012862: EUDAMED states Yes, FDA GUDID states No.

Manufacturer details

EUDAMED SRN
US-MF-000011350
Authorised representative
MDSS GmbH DE-AR-000005430

Related devices

Category: Surgical implant template, reusable

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS INSTRUMENTS, REUSABLE - OTHER.

Other devices from Tyber Medical

See all devices from Tyber Medical →

Properties

  • Sterilise before use YesEUDAMEDNoGUDID
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)