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CamAPS FX

by CamDiab 2 variants

Ref AFX0002

CamAPS FX (AFX0002) is a Class III device made by CamDiab, registered in EUDAMED on 4 Jun 2026 (Basic UDI-DI ++G008CAMAPSFX01B8), active as of 7 Nov 2026.

Active European Union

CE MDR

Valid until

13 Mar 2029

CE MDR certificate

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++G008CAMAPSFX01B8 Basic UDI-DI +G008AFX00021UDI-DIDate4 Jun 2026RegisteredStatusActive

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  • Withdrawn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 Active

Specification

EUDAMED

Model / reference
AFX0002
Primary DI / UDI-DI
+G008AFX00021
Basic UDI-DI
++G008CAMAPSFX01B8
Direct marketing DI
+G008AFX00021
EMDN code
Z12040211 Artificial pancreas
Device class
Class III
Special device type
Software
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

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

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Properties

Other properties (14, all answered No)