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Pedi-lite+ Spirometry Kit, pediatric, 2m/7ft

by GE Healthcare Finland Oy

Ref 8002718

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

CE MDD

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00840682102865 Basic UDI-DI 00840682102865UDI-DIDate17 Dec 2021RegisteredStatusActive
United StatesGUDID listing GUDID Number00840682102865 UDI-DI Date15 Aug 2016ListedStatusListed GUDID: in commercial distribution

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.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic name
Gas-sampling/monitoring respiratory tubing, single-use
Device name
Pedi-lite+ Spirometry Kit, pediatric, 2m/7ft
Model / reference
8002718, Pedi-lite Spirometry Kit 2m
Primary DI / UDI-DI
00840682102865
Basic UDI-DI
B-00840682102865
FDA product code
CAP, CBS, BZL, NHP, CBQ, CBR, BZK, NHO, CCL, NHQ, CCK
EMDN code
Z1203020285 Multi-parameter monitors - consumables
GMDN term
Gas-sampling/monitoring respiratory tubing, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
868.2600, 868.1620, 868.1730, 868.1500, 868.1700, 868.1850, 868.1720, 868.1400
EU registration type
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
8002718
GUDID
Pedi-lite Spirometry Kit 2m, 8002718
Device classEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
FI-MF-000001176

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Properties

  • Single use
  • Prescription use
  • Lot / batch number

Other properties (20)

  • Supplied sterile: No
  • Sterilise before use: No
  • Implantable: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: 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