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uMEC15S Patient Monitor

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref uMEC15SModel uMEC6, uMEC15S, uMEC15, uMEC10, uMEC7, uMEC12

by Shenzhen Mindray Bio-Medical Electronics Co.

Identity

Trade Name
Patient Monitor EUDAMED
uMEC15S Patient Monitor FDA UDI
Generic Name
General-purpose multi-parameter bedside monitor FDA UDI
Device Name
Patient Monitor EUDAMED
Model / Reference
uMEC15S EUDAMEDFDA UDI
uMEC6, uMEC15S, uMEC15, uMEC10, uMEC7, uMEC12 EUDAMED

Identifiers

Primary DI / UDI-DI
06936415912406 EUDAMEDFDA UDI
Basic UDI-DI
B-06936415912406 EUDAMED
FDA Product Code
MHX FDA UDI
EMDN Code
Z1203020201 MULTI–PARAMETER PATIENT BEDSIDE MONITORS EUDAMED
GMDN Term
General-purpose multi-parameter bedside monitor FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
870.1025 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

uMEC15S Patient Monitor by Shenzhen Mindray Bio-Medical Electronics Co. — Class II — FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

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 (2)

  • FDA UDI f3d0674f-d83e-46f1-9fbc-11b377a09f0b 32 fields · synced Oct 7, 2026
  • EUDAMED da0b16d1-2b62-41db-a8af-10f55682e91b 61 fields · synced Jul 9, 2026