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Safety-Multifly®-Needle 85.1638.205

by Sarstedt Aktiengesellschaft & Co.KG

Ref 85.1638.205

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

CE MDR

Valid until

Not listed

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

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/MDR EUDAMED Number4038917SARTD04100S66 Basic UDI-DI 04038917423915UDI-DIDate23 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04038917423915 UDI-DI Date30 Sep 2019ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Safety-Multifly® 21G 80mm lang EUDAMED
Safety-Multifly®-Needle GUDID
Generic Name
Blood collection set, invasive
Device Name
(safety) Multifly®-Kanüle
Model / Ref / Catalog
85.1638.205
Primary DI / UDI-DI
04038917423915
Basic UDI-DI
4038917SARTD04100S66
Unit of Use DI
04038917204712
FDA Product Code
JKA, FPA
EMDN Code
A01010201 Butterfly needles, with safety systems
GMDN Term
Blood collection set, invasive
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
862.1675, 880.5440
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Blood collection set, invasive

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No