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Ultrasonic Nebulisers

by Dongguan SIMZO Electronic Technology Co., Ltd.

Ref NBM-1

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

CE MDR

Valid until

6 Mar 2030

CE MDR certificate

FDA recalls

None found

in data synced 25 Oct 2026

Documents

1 certificate

Certifier SGS Belgium NV

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberCN25/00001354 Date26 May 2026IssuedStatusActive expires 6 Mar 2030
United StatesGUDID listing GUDID Number06959989131653 UDI-DI Date15 Feb 2025ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • CN25/00001354 Active Supplemented

    Quality management system EU MDR

    Certifier
    SGS Belgium NV 1639
    Issued
    26 May 2026
    Expires
    6 Mar 2030
    Reason
    Change approved

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 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  • Withdrawn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
Ultrasonic Nebulisers EUDAMED
Anthsania GUDID
Generic Name
Therapeutic agent nebulizer, ambulatory
Device Name
Portable (Ultrasonic) Nebulizer
Model / Reference
NBM-1
Primary DI / UDI-DI
06959989131653 EUDAMED
00810021174266 GUDID
Basic UDI-DI
69599891XZNEB0001KC
Direct Marketing DI
06959989131653
510(k) Number
FDA Product Code
CAF
EMDN Code
Z12040210 Ultrasonic nebulisers
GMDN Term
Therapeutic agent nebulizer, ambulatory
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
868.5630
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
06959989131653
GUDID
00810021174266
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000015642
Authorised representative
MedPath GmbH DE-AR-000000087

Other devices from Dongguan SIMZO Electronic Technology Co., Ltd.

See all devices from Dongguan SIMZO Electronic Technology Co., Ltd. →

Properties

  • Administering Medicine
  • Lot / Batch 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
  • Measuring Function: 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