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MULTIGEN PLUS Knee Balancer

by Limacorporate

Ref 9066.64.010Model MULTIGEN Plus - Balancer, 80333902A076C9

MULTIGEN PLUS Knee Balancer (9066.64.010) is a device classified as Class IIa in the EU and Class II in the US made by Limacorporate, registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI B-08033390084123), cleared under FDA 510(k) K151266 on 6 Oct 2015 and listed in FDA GUDID since 31 Aug 2016 (UDI-DI 08033390084123), active as of 7 Nov 2026.

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

CE MDR 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) K151266

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberB-08033390084123 Basic UDI-DI 08033390084123UDI-DIDate6 Nov 2026RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-08033390084123 Basic UDI-DI 08033390084123UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08033390084123 UDI-DI Date31 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK151266 Date6 Oct 2015DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08033390084123 registered 6 Nov 2026 Active· +1 more in the status table
  • FDA 510(k) K151266 decided 6 Oct 2015 Active
  • FDA GUDID UDI-DI 08033390084123 listed 31 Aug 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K151266
  2. Listed FDA GUDID 08033390084123
  3. Registered EUDAMED B-08033390084123

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
MULTIGEN Plus - Balancer EUDAMED
MULTIGEN PLUS Knee GUDID
Generic name
Orthopaedic knee-balance analyser, non-electrical
Model / Ref / Catalog
MULTIGEN Plus - Balancer, 9066.64.010, 80333902A076C9, Balancer
Primary DI / UDI-DI
08033390084123
Basic UDI-DI
B-08033390084123, 80333902A076C9
510(k) Number
FDA product code
JWH
EMDN code
L0999, V030201
GMDN term
Orthopaedic knee-balance analyser, non-electrical
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.3560
EU registration type
Legacy device (under a directive)
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
MULTIGEN Plus - Balancer
9066.64.010
80333902A076C9
GUDID
Balancer
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Orthopaedic knee-balance analyser, non-electrical

Cleared under the same submission (K151266)

and 8 more cleared under K151266

Similar devices in this category

Other devices filed under CALIPERS.

Other devices from Limacorporate

See all devices from Limacorporate →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)