← Back to catalogue

Comen

FDA UDI

Class II (US FDA UDI)

by Shenzhen Comen Medical Instruments Co., LTD.

Identity

Trade Name
Comen FDA UDI
Generic Name
Multiple vital physiological parameter monitoring system, clinical FDA UDI
Model / Reference
C80 FDA UDI

Identifiers

Primary DI / UDI-DI
06945429082548 FDA UDI
510(k) Number
K112877 FDA UDI
FDA Product Code
DQA FDA UDI
DPS FDA UDI
DXN FDA UDI
FLL FDA UDI
MWI FDA UDI
GMDN Term
Multiple vital physiological parameter monitoring system, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2700 FDA UDI
870.2340 FDA UDI
870.1130 FDA UDI
880.2910 FDA UDI
870.2300 FDA UDI
Commercial Distribution
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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Multiple vital physiological parameter monitoring system, clinical

Comen by Shenzhen Comen Medical Instruments Co., LTD. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple vital physiological parameter monitoring system, clinical.

Cleared under the same submission

K112877 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Shenzhen Comen Medical Instruments Co., LTD.

Sources (1)

  • FDA UDI 887996ea-58c7-40d5-832e-727b2cec5ee0 33 fields · synced May 30, 2026