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CUFF, DIS, NEO, CM1500B, 4.3-8, 20 (1ea=20p) 001B-30-70693

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

Ref CM1500B(001B-30-70693)Model CM1103

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

1 closed

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/MDR EUDAMED Number69449040AB0100000232 Basic UDI-DI 06944904005249UDI-DIDate30 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06944904005249 UDI-DI Date23 Sep 2016ListedStatusListed 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

1 recall · FDA

    • Terminated Z-2549-2016 FDA Class II initiated 23 Jun 2016

    Mindray has identified a potential leakage issue with the CO2 Module's Dryline II Water Trap used with the Passport Series Patient Monitor.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
NIBP Cuff EUDAMED
CUFF,DIS,NEO,CM1500B,4.3-8,20 (1ea=20p) GUDID
Generic Name
Blood pressure cuff, reusable
Device Name
NIBP Accessory
Model / Reference
CM1103 EUDAMED
CM1500B(001B-30-70693) EUDAMED
001B-30-70693 GUDID
Primary DI / UDI-DI
06944904005249
Basic UDI-DI
69449040AB0100000232
510(k) Number
FDA Product Code
MHX
EMDN Code
Z1203020302 Non–invasive blood pressure monitoring instruments
GMDN Term
Blood pressure cuff, reusable
Device Class
Class I 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 · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
CM1103
CM1500B(001B-30-70693)
GUDID
001B-30-70693
Device ClassEUDAMED
Class I
GUDID
Class II

Related devices

Category: Blood pressure cuff, reusable

Cleared under the same submission (K143195)

Show all (12)

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

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Properties

  • Measuring Function
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (20)

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