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Patient Monitor

FDA UDI

Class II (US FDA UDI)

by Shenzhen Mindray Bio-Medical Electronics Co.

Identity

Trade Name
Patient Monitor FDA UDI
Generic Name
General-purpose multi-parameter bedside monitor FDA UDI
Model / Reference
ePM 10 FDA UDI

Identifiers

Primary DI / UDI-DI
06936415927196 FDA UDI
FDA Product Code
MHX FDA UDI
GMDN Term
General-purpose multi-parameter bedside monitor FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1025 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

No

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: General-purpose multi-parameter bedside monitor

Patient Monitor by Shenzhen Mindray Bio-Medical Electronics Co. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General-purpose multi-parameter bedside monitor.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Shenzhen Mindray Bio-Medical Electronics Co.

Sources (1)

  • FDA UDI 021c4614-3a83-4a98-b3ff-ac4ebf0f8b4a 32 fields · synced May 31, 2026