Skip to content

CamAPS HX

by CamDiab 2 variants

Ref IHX0002

CamAPS HX (IHX0002) is a Class III device made by CamDiab, registered in EUDAMED on 28 Jul 2026 (Basic UDI-DI ++G008CAMAPSHX01BN), withdrawn as of 7 Nov 2026.

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE MDR, withdrawn

Ended

Withdrawn

Date not published (CE MDR)

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++G008CAMAPSHX01BN Basic UDI-DI +G008IHX00021UDI-DIDate28 Jul 2026RegisteredStatusWithdrawn No longer placed on the EU market

Official records

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 757281 Active Supplemented

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    18 Jun 2026
    Expires
    13 Mar 2029
    Reason
    Change approved

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Withdrawn

Specification

EUDAMED

Model / reference
IHX0002
Primary DI / UDI-DI
+G008IHX00021
Basic UDI-DI
++G008CAMAPSHX01BN
Direct marketing DI
+G008IHX00021
EMDN code
Z12040211 Artificial pancreas
Device class
Class III
Special device type
Software
EU registration type
Standard device

Manufacturer details

EUDAMED SRN
GB-MF-000001893
Authorised representative
AR Experts B.V. NL-AR-000023989

Similar devices in this category

Other devices filed under GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS.

Other devices from CamDiab

See all devices from CamDiab →

Properties

Other properties (14, all answered No)