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Safeway

by Lifelong Meditech Private Limited

Ref A1382Model 1mL,2mL, 2.5mL,3mL,5mL,10mL,20mL,50mL and 60mL510(k) K210103

Safeway (A1382) is a medical device (EU MDR Class IIa; FDA Class II; FDA product code FMF; EMDN category syringes) made by Lifelong Meditech Private Limited, registered in EUDAMED on 22 Jun 2023 (Basic UDI-DI 890615878LML001LU) and cleared under FDA 510(k) K210103 on 16 Jul 2021, active as of 24 Oct 2026.

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K210103↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number890615878LML001LU Basic UDI-DI 08906158781117UDI-DIDate22 Jun 2023RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK210103 Date16 Jul 2021ClearedStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 890615878LML001LU registered 22 Jun 2023 Active
  • FDA 510(k) K210103 decided 16 Jul 2021 Active

Timeline

2 dated events

  1. Cleared FDA 510(k) K210103
  2. Registered EUDAMED 890615878LML001LU

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k)

Device name
Sterile hypodermice syringe with and without needle
Model / reference
1mL, 2mL, 2.5mL, 3mL, 5mL, 10mL, 20mL, 50mL and 60mL, A1382
Primary DI / UDI-DI
08906158781117
Basic UDI-DI
890615878LML001LU
510(k) Number
FDA product code
FMF
EMDN code
A020199 Syringes, single-use - other
Device class
Class IIa EUDAMED
Class II 510(k)
Regulation
21 CFR Part 880.5860
System or procedure pack
Procedure pack which is a device in itself
EU registration type
Standard device
EU market of registration
France
Advisory committee
General Hospital
FDA decision
SESE Substantially Equivalent

Truth per registry

2 sources · 1 field differs

FieldEUDAMED510(k)
Device classEUDAMED
Class IIa
510(k)
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA 510(k)). EU and US classes are different schemes, so this is not a disagreement.

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Manufacturer details

EUDAMED SRN
IN-MF-000013835
Authorised representative
Meddevices Lifesciences B.V. NL-AR-000000594

Similar devices in this category

Other devices filed under SYRINGES, SINGLE-USE - OTHER.

Other devices from Lifelong Meditech Private Limited

See all devices from Lifelong Meditech Private Limited →

Properties

  • Supplied sterile
  • Administering medicine
Other properties (12, all answered No)