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InnoSpire Go Mouthpiece Assembly

by Respironics Respiratory Drug Delivery (UK) Ltd

Ref 1128501Model InnoSpire Go

Active Active in United States. Withdrawn in European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDD, withdrawn 510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K170853↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00383730003962 Basic UDI-DI 00383730003962UDI-DIDate23 Jul 2025RegisteredStatusWithdrawn No longer placed on the EU market
United StatesGUDID listing GUDID Number00383730003962 UDI-DI Date9 Nov 2018ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k) 510(k) NumberK170853 Date2 Nov 2017IssuedStatusActive

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  • Withdrawn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
  • United States FDA 510(k) Active
  • European Union CE/MDD Withdrawn

Specification

EUDAMED · 510(k) · GUDID

Generic Name
Therapeutic agent nebulizer, benchtop
Model / Ref / Catalog
InnoSpire Go, 1128501, 00
Primary DI / UDI-DI
00383730003962
Basic UDI-DI
B-00383730003962
510(k) Number
FDA Product Code
CAF
EMDN Code
Z12040210 Ultrasonic nebulisers
GMDN Term
Therapeutic agent nebulizer, benchtop
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
868.5630
EU market of registration
Belgium
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
InnoSpire Go
1128501
GUDID
00
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
GB-MF-000002292
Authorised representative
Philips Medical Systems Nederland B.V. NL-AR-000001422

Other devices from Respironics Respiratory Drug Delivery (UK) Ltd

See all devices from Respironics Respiratory Drug Delivery (UK) Ltd →

Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: 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
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No