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3L Bottle W/TRANSFER UNIT LB GER 77.575.400

by Sarstedt Aktiengesellschaft & Co.KG

Ref 77.575.400

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

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number4038917SARTD02101U5P Basic UDI-DIDate14 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04038917241748 UDI-DIDate31 Aug 2026ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

No notified-body 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  • Withdrawn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
3l Flasche mit Transfereinheit EUDAMED
3L Bottle W/TRANSFER UNIT LB GER GUDID
Generic Name
Non-evacuated urine specimen container IVD, no additive
Device Name
Uringefäße
Model / Ref / Catalog
77.575.400
Primary DI / UDI-DI
04038917241748
Basic UDI-DI
4038917SARTD02101U5P
Unit of Use DI
04038917241755
FDA Product Code
NNK
EMDN Code
W05010203 Urine collection, containers
GMDN Term
Non-evacuated urine specimen container IVD, no additive
Device Class
Class A EUDAMED
Class I GUDID
Regulation Number
864.3250
Market of Registration
Germany
GUDID distribution status
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