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NIBP Cuff

by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. 5 variants

Ref CM1500A(125-000596-00), CM1500A(125-000046-00), CM1500A(125-000601-00), CM1500C(125-000053-00), CM1103(115-020375-00), CM1500C(125-000048-00), CM1503(115-054843-00), CM1500C(125-000598-00), CM1300(040-000968-00), CM1505(001B-30-70701), CM1505(115-054846-00), CM1503(115-027565-00), CM1507(115-054850-00), CM1500E(125-000050-00), CM1200(125-000179-00), CM1301(040-000973-00), CM1201(0010-30-43113), CM1300E(115-057850-00), CM1500B(001B-30-70678), CM1500E(001B-30-70681), CM1506(115-016969-00), CM1300D(115-057849-00), CM1500E(125-000600-00), CM1504(001B-30-70700), CM1500D(125-000599-00), CM1204(0010-30-12160), CM1503(001B-30-70699), CM1303(115-022789-00), CM1302(040-000978-00), CM1703(115-052297-00), CM1500C(115-054834-00), CM1304(040-000988-00), CM1202(0010-30-12158), CM1500E(001B-30-70696), CM1702A(125-000624-00), CM1500D(125-000604-00), CM1505(115-027567-00), CM1501(001B-30-70682), CM1203(0010-30-43115), CM1500E(125-000605-00), CM1202(125-000592-00)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

2 closed

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69449040AB0100000232 Basic UDI-DI Date30 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06903053083942 UDI-DI Date28 Jul 2020ListedStatusListed 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

2 recalls · FDA

    • Terminated Z-0236-2020 FDA Class II initiated 1 Oct 2019 on shared 510(k) K182821

    NIBP valve assembly board subject to this recall includes enhancements that are not included in the current marketing clearance:1. Anti-motion feature 2. NIBP hose blockage identification function

    • 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.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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
Disposable adult blood cuff(CM1503) GUDID
CUFF,DIS,NEO,CM1500B,4.3-8(1) GUDID
single-patient neonate blood cuff 5#(CM1 GUDID
Disposable adult thigh blood cuff(CM1505) GUDID
Cuff with connector GUDID
Cuff GUDID
Generic Name
Blood pressure cuff, reusable
Blood pressure cuff, single-use
Device Name
NIBP Accessory
Model / Reference
CM1103 EUDAMED
CM1500A(125-000596-00) EUDAMED
CM1500A(125-000046-00) EUDAMED
CM1500A(125-000601-00) EUDAMED
CM1500C(125-000053-00) EUDAMED
CM1103(115-020375-00) EUDAMED
CM1500C(125-000048-00) EUDAMED
CM1503(115-054843-00) EUDAMED
CM1500C(125-000598-00) EUDAMED
CM1300(040-000968-00) EUDAMED
CM1505(001B-30-70701) EUDAMED
CM1505(115-054846-00) EUDAMED
CM1503(115-027565-00) EUDAMED
CM1507(115-054850-00) EUDAMED
CM1500E(125-000050-00) EUDAMED
CM1200(125-000179-00) EUDAMED
CM1301(040-000973-00) EUDAMED
CM1201(0010-30-43113) EUDAMED
CM1300E(115-057850-00) EUDAMED
CM1500B(001B-30-70678) EUDAMED
CM1500E(001B-30-70681) EUDAMED
CM1506(115-016969-00) EUDAMED
CM1300D(115-057849-00) EUDAMED
CM1500E(125-000600-00) EUDAMED
CM1504(001B-30-70700) EUDAMED
CM1500D(125-000599-00) EUDAMED
CM1204(0010-30-12160) EUDAMED
CM1503(001B-30-70699) EUDAMED
CM1303(115-022789-00) EUDAMED
CM1302(040-000978-00) EUDAMED
CM1703(115-052297-00) EUDAMED
CM1500C(115-054834-00) EUDAMED
CM1304(040-000988-00) EUDAMED
CM1202(0010-30-12158) EUDAMED
CM1500E(001B-30-70696) EUDAMED
CM1702A(125-000624-00) EUDAMED
CM1500D(125-000604-00) EUDAMED
CM1505(115-027567-00) EUDAMED
CM1501(001B-30-70682) EUDAMED
CM1203(0010-30-43115) EUDAMED
CM1500E(125-000605-00) EUDAMED
CM1202(125-000592-00) EUDAMED
115-054843-00 GUDID
001B-30-70678 GUDID
001B-30-70681 GUDID
115-054846-00 GUDID
0010-30-12158 GUDID
0010-30-12160 GUDID
Primary DI / UDI-DI
06903053083942, 06936415978587, 06903053083225, 06936415978648, 06936415903978, 06944904061436, 06944904061450, 06936415903992, 06944904003917, 06944904003931, 06936415905309, 06936415978563, 06903053083966, 06944904035239, 06944904005317, 06944904090641, 06936415904012, 06936415978600, 06903053005425, 06944904039855, 06903053105866, 06936415988142, 06936415901530, 06936415988135, 06903053083980, 06944904005300, 06903053083997, 06944904005294, 06903053105972, 06944904039862, 06903053097543, 06936415903923, 06944904039886, 06944904040523, 06903053071321, 06903053083256, 06944904090665, 06936415900861, 06903053105873, 06903053083164, 06903053083232
Basic UDI-DI
69449040AB0100000232
510(k) Number
FDA Product Code
DXQ, MHX
EMDN Code
Z1203020302 Non–invasive blood pressure monitoring instruments
GMDN Term
Blood pressure cuff, reusable
Blood pressure cuff, single-use
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
870.1120, 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
CM1500A(125-000596-00)
CM1500A(125-000046-00)
CM1500A(125-000601-00)
CM1500C(125-000053-00)
CM1103(115-020375-00)
CM1500C(125-000048-00)
CM1503(115-054843-00)
CM1500C(125-000598-00)
CM1300(040-000968-00)
CM1505(001B-30-70701)
CM1505(115-054846-00)
CM1503(115-027565-00)
CM1507(115-054850-00)
CM1500E(125-000050-00)
CM1200(125-000179-00)
CM1301(040-000973-00)
CM1201(0010-30-43113)
CM1300E(115-057850-00)
CM1500B(001B-30-70678)
CM1500E(001B-30-70681)
CM1506(115-016969-00)
CM1300D(115-057849-00)
CM1500E(125-000600-00)
CM1504(001B-30-70700)
CM1500D(125-000599-00)
CM1204(0010-30-12160)
CM1503(001B-30-70699)
CM1303(115-022789-00)
CM1302(040-000978-00)
CM1703(115-052297-00)
CM1500C(115-054834-00)
CM1304(040-000988-00)
CM1202(0010-30-12158)
CM1500E(001B-30-70696)
CM1702A(125-000624-00)
CM1500D(125-000604-00)
CM1505(115-027567-00)
CM1501(001B-30-70682)
CM1203(0010-30-43115)
CM1500E(125-000605-00)
CM1202(125-000592-00)
GUDID
115-054843-00
001B-30-70678
001B-30-70681
115-054846-00
0010-30-12158
0010-30-12160
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000014156
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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

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

Properties

  • Single Use YesGUDIDNoGUDID
  • Measuring Function
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date YesGUDIDNoGUDID
  • Manufacturing Date

Other properties (18)

  • Sterile: 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