IGH Plus Breakapart Probe

Ref CE-LPH 070

IGH Plus Breakapart Probe (CE-LPH 070) is a Class C device made by Cytocell, Ltd., registered in EUDAMED on 23 Oct 2026 (Basic UDI-DI 50558449LPH070JL), active as of 7 Nov 2026.

Active European Union

CE IVDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	Number50558449LPH070JL Basic UDI-DI 05055844936812UDI-DI	Date23 Oct 2026Registered	StatusActive

Official records

EUDAMED public site Basic UDI-DI 50558449LPH070JL — open Devices and search for it

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Model / reference: CE-LPH 070

Primary DI / UDI-DI: 05055844936812
Basic UDI-DI: 50558449LPH070JL
EMDN code: W01060299 Tests for acquired genetic or chromosomal alterations - other

Device class: Class C
EU registration type: Standard device
EU market of registration: Germany

Manufacturer details

EUDAMED SRN: GB-MF-000016893
Authorised representative: Sysmex Europe SE DE-AR-000022333

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See all devices from Cytocell, Ltd. →

Properties

Reagent
IVD kit
Professional testing

Other properties (10, all answered No)