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Membrane-Adapter 14.1112

by Sarstedt Aktiengesellschaft & Co.KG

Ref 14.1112

Membrane-Adapter 14.1112 is a device classified as IVD General (EU), Class II (US) made by Sarstedt Aktiengesellschaft & Co.KG, registered in EUDAMED on 20 Oct 2026 (Basic UDI-DI B-04038917085359) and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 04038917085359), active as of 9 Nov 2026.

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

CE IVDD

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

Source EUDAMED, GUDID, synced 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-04038917085359 Basic UDI-DI 04038917085359UDI-DIDate20 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04038917085359 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04038917085359 registered 20 Oct 2026 Active
  • FDA GUDID UDI-DI 04038917085359 listed 16 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04038917085359
  2. Registered EUDAMED B-04038917085359

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Membrane-Adapter
Generic name
Blood collection tube spike syringe adaptor
Model / Ref / Catalog
14.1112
Primary DI / UDI-DI
04038917085359
Basic UDI-DI
B-04038917085359
FDA product code
JKA
EMDN code
W0501010180 Venous or arterious blood collection devices - accessories
GMDN term
Blood collection tube spike syringe adaptor
Device class
Class IVD General EUDAMED
Class II GUDID
Regulation number
862.1675
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IVD General
GUDID
Class II

Device class is stated on each registry's own scale: Class IVD General 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 spike syringe adaptor

Similar devices in this category

Other devices filed under VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - ACCESSORIES.

Other devices from Sarstedt Aktiengesellschaft & Co.KG

See all devices from Sarstedt Aktiengesellschaft & Co.KG →

Properties

  • Supplied sterile
  • Single use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)