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Adapter sleeve 14.1216

by Sarstedt Aktiengesellschaft & Co.KG

Ref 14.1216

Adapter sleeve 14.1216 is a device classified as Class A in the EU and Class II in the US made by Sarstedt Aktiengesellschaft & Co.KG, registered in EUDAMED on 13 Oct 2026 (Basic UDI-DI 4038917SARTD06500U7U) and listed in FDA GUDID since 26 Apr 2024 (UDI-DI 04038917418867), 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 Number4038917SARTD06500U7U Basic UDI-DI 04038917418867UDI-DIDate13 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04038917418867 UDI-DI Date26 Apr 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4038917SARTD06500U7U registered 13 Oct 2026 Active
  • FDA GUDID UDI-DI 04038917418867 listed 26 Apr 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 04038917418867
  2. Registered EUDAMED 4038917SARTD06500U7U

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  • Withdrawn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
Adapterkappe EUDAMED
Adapter sleeve GUDID
Generic name
Blood collection tube holder, single-use
Model / Ref / Catalog
14.1216
Primary DI / UDI-DI
04038917418867
Basic UDI-DI
4038917SARTD06500U7U
Unit of use DI
04038917418874
FDA product code
JKA
EMDN code
W0580 IVD general use consumables devices - other accessories
GMDN term
Blood collection tube holder, single-use
Device class
Class A EUDAMED
Class II GUDID
Regulation number
862.1675
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 II

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

Related devices

Category: Blood collection tube holder, single-use

Similar devices in this category

Other devices filed under IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES.

Other devices from Sarstedt Aktiengesellschaft & Co.KG

See all devices from Sarstedt Aktiengesellschaft & Co.KG →

Properties

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