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Patient Spirometry Tubes

by GE Healthcare Finland Oy 2 variants

Ref 884101

Patient Spirometry Tubes (884101) is a device classified as Class I and Class IIa in the EU and Class II in the US made by GE Healthcare Finland Oy, registered in EUDAMED on 3 Jul 2025 (Basic UDI-DI 08406821BUG004797T) and listed in FDA GUDID since 15 Aug 2016 (UDI-DI 00840682103626), active as of 22 Oct 2026.

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

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08406821BUG004797T Basic UDI-DI 00840682103626UDI-DIDate3 Jul 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00840682103626 UDI-DI Date15 Aug 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08406821BUG004797T registered 3 Jul 2025 Active
  • FDA GUDID UDI-DI 00840682103626 listed 15 Aug 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00840682103626
  2. Registered EUDAMED 08406821BUG004797T

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  • Withdrawn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

Generic name
Gas-sampling/monitoring respiratory tubing, single-use
Model / reference
884101 EUDAMED
Spirometry Tube GUDID
disposable GUDID
3m/10ft GUDID
Primary DI / UDI-DI
00840682103626
Basic UDI-DI
08406821BUG004797T, B-00840682103626
FDA product code
CBQ, CBR, BZL, CBS, NHQ, CAP, NHP, CCL, NHO, BZK, CCK
EMDN code
Z1203020285 Multi-parameter monitors - consumables
GMDN term
Gas-sampling/monitoring respiratory tubing, single-use
Device class
Class I EUDAMED
Class IIa EUDAMED
Class II GUDID
Regulation number
868.1500, 868.1700, 868.1730, 868.1620, 868.2600, 868.1720, 868.1850, 868.1400
EU registration type
Standard device
Legacy device (under a directive)
EU market of registration
Finland
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
884101
GUDID
Spirometry Tube, disposable, 3m/10ft
Device classEUDAMED
Class I
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class I and Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes.

Manufacturer details

EUDAMED SRN
FI-MF-000001176

Related devices

Category: General-purpose multi-parameter bedside monitor

Similar devices in this category

Other devices filed under MULTI–PARAMETER PATIENT MONITORS.

Other devices from GE Healthcare Finland Oy

See all devices from GE Healthcare Finland Oy →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
Other properties (22, all answered No)