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Suru

by Suru International Pvt Ltd 82 variants

Ref 4006AModel 4006

Suru (4006A) is a Class IIa device made by Suru International Pvt Ltd, registered in EUDAMED on 24 Oct 2026 (Basic UDI-DI B-08902141105243), active as of 7 Nov 2026.

Active European Union

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08902141105243 Basic UDI-DI 08902141105243UDI-DIDate24 Oct 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Device name
Nebulizer Mask
Model / reference
4006, 4006A
Primary DI / UDI-DI
08902141105243
Basic UDI-DI
B-08902141105243
EMDN code
R03010301 Aerosol therapy masks
Device class
Class IIa
EU registration type
Legacy device (under a directive)
EU market of registration
Bulgaria

Manufacturer details

EUDAMED SRN
IN-MF-000023736
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

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Other devices filed under AEROSOL THERAPY MASKS.

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Properties

  • Supplied sterile
Other properties (11, all answered No)