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NIBP cuff

by Orantech Inc. 282 variants

Ref BPD-30TS-W10

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 Number69416919ORANTECH06QZ Basic UDI-DI 06941691900627UDI-DIDate15 Nov 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number06941691900627 UDI-DI Date17 Oct 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  • Withdrawn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
Orantech GUDID
Generic Name
Blood pressure cuff, single-use
Model / Reference
BPD-30TS-W10
Description
TPU, Single tube, With connector Child Range 13.8-21.5cm
Primary DI / UDI-DI
06941691900627
Basic UDI-DI
69416919ORANTECH06QZ
510(k) Number
FDA Product Code
DXQ
EMDN Code
Z1203020285 Multi-parameter monitors - consumables
GMDN Term
Blood pressure cuff, single-use
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
870.1120
EU market of registration
Denmark
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000013859
Authorised representative
Medten EU ApS DK-AR-000034434

Related devices

Category: General-purpose multi-parameter bedside monitor

Other devices from Orantech Inc.

See all devices from Orantech Inc. →

Properties

  • Single Use
  • Reusable
  • Measuring Function
  • Lot / Batch Number
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Implantable: 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No