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Cranial 4Pi Basic Mask (1 pc)

by Brainlab SE

Part of a family of 18 devices: see the family page

Ref 43451-01A

Cranial 4Pi Basic Mask (1 pc) (43451-01A) is a Class I device made by Brainlab SE, registered in EUDAMED on 19 Apr 2024 (Basic UDI-DI 4056481Cranial4PiMasksEA), active as of 24 Oct 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number4056481Cranial4PiMasksEA Basic UDI-DI 04056481146924UDI-DIDate19 Apr 2024RegisteredStatusActive

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  • Withdrawn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
Cranial 4Pi Masks
Model / reference
43451-01A
Primary DI / UDI-DI
04056481146924
Basic UDI-DI
4056481Cranial4PiMasksEA
EMDN code
Z11019080 Various radiotherapy and radiosurgery instruments - hardware accessories
Device class
Class I
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000006183

Similar devices in this category

Other devices filed under VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - HARDWARE ACCESSORIES.

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Properties

Other properties (14, all answered No)