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Mindray

FDA UDI

Class I (US FDA UDI)

by Nanjing Mindray Bio-Medical Electronics Co., Ltd

Identity

Trade Name
Mindray FDA UDI
Generic Name
Instrument tray, reusable FDA UDI
Model / Reference
A44XXU Instrument tray FDA UDI

Identifiers

Primary DI / UDI-DI
06948350529878 FDA UDI
FDA Product Code
FQO FDA UDI
GMDN Term
Instrument tray, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4960 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

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Instrument tray, reusable

Mindray by Nanjing Mindray Bio-Medical Electronics Co., Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Instrument tray, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 9b51f5c4-4d1a-4a16-81a9-abcecb106cf9 32 fields · synced Jun 1, 2026