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Salivette® 51.1534.100

by Sarstedt Aktiengesellschaft & Co.KG

Ref 51.1534.100

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

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number4038917SARTD00800U6F Basic UDI-DI 04038917581882UDI-DIDate13 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04038917581882 UDI-DI Date21 Jul 2026ListedStatusListed GUDID: not in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Salivette® VD EUDAMED
Salivette® GUDID
Generic Name
Oral/upper respiratory tract specimen collection kit
Device Name
Salivette
Model / Ref / Catalog
51.1534.100
Primary DI / UDI-DI
04038917581882
Basic UDI-DI
4038917SARTD00800U6F
Unit of Use DI
04038917581899
FDA Product Code
NNK
EMDN Code
W05019002 Saliva collection devices
GMDN Term
Oral/upper respiratory tract specimen collection kit
Device Class
Class A EUDAMED
Class I GUDID
Regulation Number
864.3250
EU market of registration
Germany
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class A
GUDID
Class I

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Properties

  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (20)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No