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Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert

FDA UDI

Class II (US FDA UDI)

by Cercare Medical A/S

Identity

Trade Name
Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert FDA UDI
Generic Name
Radiological PACS software FDA UDI
Model / Reference
2023-06-01 FDA UDI

Identifiers

Primary DI / UDI-DI
05745000308071 FDA UDI
510(k) Number
K202793 FDA UDI
K230016 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 (CMN) Capillary Function with Virtual Expert by Cercare Medical A/S — Class II — FDA UDI — listed in FDA GUDID

Cleared under the same submission

K202793 also covers:

K230016 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 9fd946ee-705f-49b2-8f52-e7928052ce98 34 fields · synced May 30, 2026