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Nouyan

FDA UDI

Class II (US FDA UDI)

by Shenzhen Changkun Technology Co., Ltd.

Identity

Trade Name
NOUYAN FDA UDI
Generic Name
Blood pressure alarm FDA UDI
Model / Reference
CK-W355 FDA UDI

Identifiers

Primary DI / UDI-DI
06951727602838 FDA UDI
510(k) Number
K193386 FDA UDI
FDA Product Code
DXN FDA UDI
GMDN Term
Blood pressure alarm FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1130 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

No

FDA UDI

Over-the-Counter

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Blood pressure alarm

Nouyan by Shenzhen Changkun Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Blood pressure alarm.

Cleared under the same submission

K193386 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Shenzhen Changkun Technology Co., Ltd.

Sources (1)

  • FDA UDI 32f5da67-1ea8-4450-adee-c6901fc0cea6 33 fields · synced May 30, 2026