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uMEC10 Patient Monitor

by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Ref uMEC10Model uMEC6, uMEC15S, uMEC15, uMEC10, uMEC7, uMEC12

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-06936415900175 Basic UDI-DI 06936415900175UDI-DIDate21 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06936415900175 UDI-DI Date24 Jan 2025ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Patient Monitor EUDAMED
uMEC10 Patient Monitor GUDID
Generic Name
General-purpose multi-parameter bedside monitor
Model / Reference
uMEC10, uMEC6, uMEC15S, uMEC15, uMEC7, uMEC12
Primary DI / UDI-DI
06936415900175
Basic UDI-DI
B-06936415900175
510(k) Number
FDA Product Code
MHX
EMDN Code
Z1203020201 Multi–parameter patient bedside monitors
GMDN Term
General-purpose multi-parameter bedside monitor
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
870.1025
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Cleared under the same submission (K171901)

Other devices from Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

See all devices from Shenzhen Mindray Bio-Medical Electronics Co., Ltd. →

Properties

  • Measuring Function
  • Serial Number
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No