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ENT irrigation device

by HONSUN (NANTONG) Co., Ltd. 2 variants

Ref NB-NA01

ENT irrigation device (NB-NA01) is a Class I device made by HONSUN (NANTONG) Co., Ltd., registered in EUDAMED on 15 Jan 2024 (Basic UDI-DI 697038425ENTRT), active as of 7 Nov 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697038425ENTRT Basic UDI-DI 06970384250190UDI-DIDate15 Jan 2024RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device name
ENT irrigation device
Model / reference
NB-NA01
Primary DI / UDI-DI
06970384250190
Basic UDI-DI
697038425ENTRT
EMDN code
Q0399 ENT devices - other
Device class
Class I
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000009428
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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Properties

Other properties (14, all answered No)