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Needle-guided bracket

by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. 2 variants

Ref NGB-001,PR1A-30-90212Model NGB-001

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69449040AB050100355Y Basic UDI-DI 06944904001562UDI-DIDate25 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06944904001562 UDI-DI Date20 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-1330-2020 FDA Class II initiated 13 Jan 2020 on shared 510(k) K183660

    The DP-30 displays an incorrect needle-guide bracket when used with the 65EC10EA model transducer.

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  • Withdrawn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
NGB-001 Needle-guided Bracket
Generic Name
Ultrasound imaging system tracking positioner, reusable
Device Name
Needle-guided bracket
Model / Reference
NGB-001, PR1A-30-90212
Primary DI / UDI-DI
06944904001562
Basic UDI-DI
69449040AB050100355Y
Direct Marketing DI
06944904001562
510(k) Number
FDA Product Code
OIJ
EMDN Code
A018002 Needle guides
GMDN Term
Ultrasound imaging system tracking positioner, reusable
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
892.1560
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
MRI Safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
NGB-001
NGB-001,PR1A-30-90212
GUDID
PR1A-30-90212
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

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (21)

  • 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
  • Lot / Batch Number: No
  • Expiration Date: No