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NGB-006 Needle-guided Bracket/PLAS 0022-30-90735

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

Ref NGB-006,0022-30-90735Model NGB-001

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 24 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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69449040AB050100355Y Basic UDI-DI 06944904001630UDI-DIDate25 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06944904001630 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

0 recalls · FDA

No FDA recalls found in the data synced 24 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  • Withdrawn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
NGB-006 Needle-guided Bracket/PLAS
Generic Name
Ultrasound imaging system tracking positioner, reusable
Device Name
Needle-guided bracket
Model / Reference
NGB-001, NGB-006, 0022-30-90735
Primary DI / UDI-DI
06944904001630
Basic UDI-DI
69449040AB050100355Y
Direct Marketing DI
06944904001630
510(k) Number
FDA Product Code
IYO
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
Hydrogen Peroxide
MRI Safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
NGB-001
NGB-006,0022-30-90735
GUDID
0022-30-90735
Device ClassEUDAMED
Class I
GUDID
Class II

Related devices

Category: Ultrasound imaging system tracking positioner, reusable

Cleared under the same submission (K102865)

Show all (12)

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

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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