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K2M General Instruments

by K2M, Inc. 27 variants

Ref AG01-96113Model 08858251004216SR

K2M General Instruments (AG01-96113) is a Class I device made by K2M, Inc., registered in EUDAMED on 31 Oct 2026 (Basic UDI-DI 08858251004216SR), active as of 7 Nov 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08858251004216SR Basic UDI-DI 10888857469495UDI-DIDate31 Oct 2026RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Lateral Disc Prep Container
Model / reference
08858251004216SR, AG01-96113
Primary DI / UDI-DI
10888857469495
Basic UDI-DI
08858251004216SR
Direct marketing DI
10888857469495
EMDN code
V0402 Clinical use trays and bowls
Device class
Class I
EU registration type
Standard device
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000004440
Authorised representative
Emergo Europe B.V. NL-AR-000000116

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Properties

  • Sterilise before use
Other properties (13, all answered No)