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Whale

FDA UDI

Class II (US FDA UDI)

by Beijing East Whale Imaging Technology Co., Ltd.

Identity

Trade Name
WHALE FDA UDI
Generic Name
Ultrasound mobile medical facility FDA UDI
Model / Reference
P9 FDA UDI

Identifiers

Primary DI / UDI-DI
06970528550056 FDA UDI
510(k) Number
K160343 FDA UDI
FDA Product Code
ITX FDA UDI
IYO FDA UDI
IYN FDA UDI
GMDN Term
Ultrasound mobile medical facility FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1570 FDA UDI
892.1560 FDA UDI
892.1550 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

Yes

FDA UDI

Dimensions & Sizes

Size
Width — 598 Millimeter FDA UDI
Length — 524 Millimeter FDA UDI

Category: Ultrasound mobile medical facility

Whale by Beijing East Whale Imaging Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ultrasound mobile medical facility.

Cleared under the same submission

K160343 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Beijing East Whale Imaging Technology Co., Ltd.

Sources (1)

  • FDA UDI fb8f7617-4900-42c2-9c4e-01987e283c2f 35 fields · synced Jun 8, 2026