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RespArray NIBP Cuff 01.57.472317

by Edan Instruments, Inc.

Ref RPAYACC036

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

CE MDR

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/MDR EUDAMED Number69444138NIBPCuff349 Basic UDI-DI 06944413824805UDI-DIDate5 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06944413824805 UDI-DI Date1 Sep 2022ListedStatusListed 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  • Withdrawn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/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
NIBP Cuff EUDAMED
RespArray NIBP Cuff GUDID
Generic Name
Blood pressure cuff, reusable
Model / Reference
RPAYACC036 EUDAMED
01.57.472317 GUDID
Primary DI / UDI-DI
06944413824805
Basic UDI-DI
69444138NIBPCuff349
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
RPAYACC036
GUDID
01.57.472317
Device ClassEUDAMED
Class I
GUDID
Class II

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Properties

  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No