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Cercare Medical Neurosuite with Capillary Function 16

by Cercare Medical A/S

Ref Capillary Function ver. 16

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number05745000308217 UDI-DI Date6 Dec 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number5745000308CMNCAPILLARYMC Basic UDI-DI 05745000308217UDI-DIDate19 Sep 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Capillary Function EUDAMED
Cercare Medical Neurosuite with Capillary Function GUDID
Generic Name
Radiological PACS-dedicated management software
Model / Reference
Capillary Function ver. 16 EUDAMED
16 GUDID
Primary DI / UDI-DI
05745000308217
Basic UDI-DI
5745000308CMNCAPILLARYMC
Direct Marketing DI
05745000308217
510(k) Number
FDA Product Code
LLZ
EMDN Code
Z110603 Picture archiving and communication systems
GMDN Term
Radiological PACS-dedicated management software
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.2050
Special Device Type
Software
EU market of registration
Denmark
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Capillary Function ver. 16
GUDID
16
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Cleared under the same submission (K202793)

Cleared under the same submission (K230016)

Other devices from Cercare Medical A/S

See all devices from Cercare Medical A/S →

Properties

  • Prescription Use

Other properties (23)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No