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Cercare Medical Neurosuite with Capillary Function

FDA UDI

Class II (US FDA UDI)

by Cercare Medical A/S

Identity

Trade Name
Cercare Medical Neurosuite with Capillary Function FDA UDI
Generic Name
Radiological PACS software FDA UDI
Device Name
Cercare Medical Neurosuite with Capillary Function, release 2023-02-01 and prior FDA UDI
Model / Reference
CMN with Capillary Function (MR) FDA UDI
Description
Cercare Medical Neurosuite with Capillary Function, release 2023-02-01 and prior FDA UDI

Identifiers

Primary DI / UDI-DI
05745000308019 FDA UDI
510(k) Number
K202793 FDA UDI
FDA Product Code
LLZ FDA UDI
GMDN Term
Radiological PACS software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.2050 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Cercare Medical Neurosuite with Capillary Function by Cercare Medical A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K202793 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cercare Medical A/S

Sources (1)

  • FDA UDI 7c7143e2-47bd-4aa8-8f4c-6f719121ec16 35 fields · synced Jun 8, 2026