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Archiving Cap 65.647.300

by Sarstedt Aktiengesellschaft & Co.KG

Ref 65.647.300

Archiving Cap 65.647.300 is a device classified as Class A in the EU and Class I in the US made by Sarstedt Aktiengesellschaft & Co.KG, registered in EUDAMED on 13 Oct 2026 (Basic UDI-DI 4038917SARTD03200U66) and listed in FDA GUDID since 20 Feb 2024 (UDI-DI 04038917988315), active as of 24 Oct 2026.

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

CE IVDR

Valid until

No date given

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

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number4038917SARTD03200U66 Basic UDI-DI 04038917988315UDI-DIDate13 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04038917988315 UDI-DI Date20 Feb 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4038917SARTD03200U66 registered 13 Oct 2026 Active
  • FDA GUDID UDI-DI 04038917988315 listed 20 Feb 2024 Listed

Certificates

0 certificates · EUDAMED

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

Timeline

2 dated events

  1. Listed FDA GUDID 04038917988315
  2. Registered EUDAMED 4038917SARTD03200U66

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  • Withdrawn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
Archiving Cap
Generic name
Test tube/reservoir cap
Device name
Archivierungsstopfen (ohne Filter)
Model / Ref / Catalog
65.647.300
Primary DI / UDI-DI
04038917988315
Basic UDI-DI
4038917SARTD03200U66
Unit of use DI
04038917988339
FDA product code
LXG
EMDN code
W02060285 Post-analysis sample archiving systems - consumables
GMDN term
Test tube/reservoir cap
Device class
Class A EUDAMED
Class I GUDID
Regulation number
862.2050
EU registration type
Standard device
EU 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

Device class is stated on each registry's own scale: Class A in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Test tube/reservoir cap

Similar devices in this category

Other devices filed under SAMPLE PROCESSING SYSTEMS.

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Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (22, all answered No)