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NIBP Tube

by Edan Instruments, Inc.

Ref BPT3, RPAYACC034, 01.59.036118, 01.57.472010, 01.57.471303, 01.57.471291, BPT1

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

3 ongoing

Recall on shared 510(k) K150901, K131971, K202892; other models may be affected

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 Number69444138NIBPTubeMD Basic UDI-DI Date21 Jan 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06944413812048 UDI-DI Date1 Feb 2021ListedStatusListed 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

4 recalls · 3 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-1141-2026 FDA Class II initiated 24 Oct 2025 on shared 510(k) K150901
    • Ongoing Z-1145-2026 FDA Class II initiated 24 Oct 2025 on shared 510(k) K131971
    • Ongoing Z-1144-2026 FDA Class II initiated 24 Oct 2025 on shared 510(k) K202892

    As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

    • Terminated Z-2388-2016 FDA Class II initiated 23 Jun 2016 on shared 510(k) K110922

    Incorrect CO2 readings with some patient monitors.

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  • Withdrawn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 Tube EUDAMEDGUDID
RespArray NIBP hose GUDID
Generic Name
Blood pressure cuff, reusable
Model / Reference
BPT3 EUDAMED
RPAYACC034 EUDAMED
01.59.036118 EUDAMED
01.57.472010 EUDAMED
01.57.471303 EUDAMED
01.57.471291 EUDAMED
BPT1 EUDAMED
01.57.471908 GUDID
NIBP Tube for neonatal cuff GUDID
3m GUDID
NIBP Tube GUDID
01.57.472399 GUDID
01.57.472338 GUDID
Primary DI / UDI-DI
06944413812048, 06944413804920, 06944413804791, 06944413826205, 06944413804807, 06944413807334, 06944413824775, 16944413824772, 06944413812109
Basic UDI-DI
69444138NIBPTubeMD
510(k) Number
FDA Product Code
DXQ
EMDN Code
Z12030280 Vital signs monitoring instruments - hardware accessories
GMDN Term
Blood pressure cuff, reusable
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
870.1120
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
BPT3
RPAYACC034
01.59.036118
01.57.472010
01.57.471303
01.57.471291
BPT1
GUDID
01.57.471908
NIBP Tube for neonatal cuff, 3m
NIBP Tube, 3m
01.57.472399
01.57.472338
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000009957
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Related devices

Category: Electrical-only medical device connection cable, reusable

Other devices from Edan Instruments, Inc.

See all devices from Edan Instruments, Inc. →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Serial Number NoGUDIDYesGUDID
  • Expiration Date YesGUDIDNoGUDID
  • Manufacturing Date

Other properties (19)

  • 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No