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Neptune 0703146005

by Stryker Corp.

Ref 0703-146-005Model 08858251002025S2

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251002025S2 Basic UDI-DI 07613327548235UDI-DIDate2 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327548235 UDI-DI Date7 Aug 2026ListedStatusListed 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  • Withdrawn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/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Neptune
Generic name
Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
Device name
Neptune SafeAir Pencils
Model / Ref / Catalog
08858251002025S2, 0703-146-005, 0703146005
Primary DI / UDI-DI
07613327548235
Basic UDI-DI
08858251002025S2
FDA product code
GEI
EMDN code
K02010107 Smoke evacuation systems
GMDN term
Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4400
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
08858251002025S2
0703-146-005
GUDID
0703146005
Device classEUDAMED
Class IIb
GUDID
Class II

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Properties

  • Supplied sterile
  • Single use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
  • Expiration date

Other properties (19)

  • 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
  • Contains endocrine-disrupting substances: 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
  • Manufacturing date: No