CoroFlow

FDA UDI

Class II (US FDA UDI)

by COROVENTIS Research AB

Identity

Trade Name: CoroFlow FDA UDI
Generic Name: Cardiac catheterization laboratory computer FDA UDI
Model / Reference: 12000 FDA UDI

Identifiers

Primary DI / UDI-DI: 07350111070014 FDA UDI
510(k) Number: K201881 FDA UDI
FDA Product Code: DQK FDA UDI
OUG FDA UDI
GMDN Term: Cardiac catheterization laboratory computer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1425 FDA UDI
880.6310 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Cardiac catheterization laboratory computer

CoroFlow by COROVENTIS Research AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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OptoMonitor 3 — Opsens · Class II
OptoMonitor 3 — Opsens · Class II
OptoMonitor 3 — Opsens · Class II
OptoMonitor 3 — Opsens · Class II

Cleared under the same submission

K201881 also covers:

CoroFlow Upgrade kit — COROVENTIS Research AB

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: COROVENTIS Research AB

Sources (1)

FDA UDI 0db45424-6b73-4c1e-900b-e607d7720e39 33 fields · synced May 31, 2026