Anke

FDA UDI

Class II (US FDA UDI)

by Shenzhen Anke High-Tech Co., Ltd.

Identity

Trade Name: ANKE FDA UDI
Generic Name: Full-body MRI system, permanent magnet FDA UDI
Device Name: Magnetic Resonance Imaging System, Model: ASM-050P or OPENMARK 5000 FDA UDI
Model / Reference: ASM-050P (OPENMARK 5000) FDA UDI
Description: Magnetic Resonance Imaging System, Model: ASM-050P or OPENMARK 5000 FDA UDI

Identifiers

Primary DI / UDI-DI: 06950743801058 FDA UDI
510(k) Number: K113281 FDA UDI
FDA Product Code: LNH FDA UDI
GMDN Term: Full-body MRI system, permanent magnet FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1000 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

Yes

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Full-body MRI system, permanent magnet

Anke by Shenzhen Anke High-Tech Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Shenzhen Anke High-Tech Co., Ltd.

Sources (1)

FDA UDI c16c35ae-61de-42f1-8e96-a9abcdceb4e9 34 fields · synced Jun 1, 2026