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Micsafe 1

by Jiangsu Micsafe Medical Tehcnology Co., LTD. 13 variants

Ref ISY05F31516Model 0.5ml 31G*5/16

Micsafe 1 is a device classified as Class IIa in the EU and Class II in the US made by Jiangsu Micsafe Medical Tehcnology Co., LTD., registered in EUDAMED on 18 May 2026 (Basic UDI-DI B-06971911296513) and listed in FDA GUDID since 22 Nov 2022 (UDI-DI 06971911296513), active as of 22 Oct 2026.

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

CE MDD

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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-06971911296513 Basic UDI-DI 06971911296513UDI-DIDate18 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06971911296513 UDI-DI Date22 Nov 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-06971911296513 registered 18 May 2026 Active
  • FDA GUDID UDI-DI 06971911296513 listed 22 Nov 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 06971911296513
  2. Registered EUDAMED B-06971911296513

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Syringe for Insulin EUDAMED
Micsafe GUDID
Generic name
Insulin syringe/needle, basic
Model / reference
0.5ml 31G*5/16 EUDAMED
ISY05F31516 EUDAMED
1 GUDID
Primary DI / UDI-DI
06971911296513
Basic UDI-DI
B-06971911296513
FDA product code
FMF, MEG
EMDN code
A02010602 Insulin syringes w/o fixed needles, single-use
GMDN term
Insulin syringe/needle, basic
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
880.5860
System or procedure pack
System which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
0.5ml 31G*5/16
ISY05F31516
GUDID
1
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Insulin syringe/needle, basic

Similar devices in this category

Other devices filed under INSULIN SYRINGES W/O FIXED NEEDLES, SINGLE-USE.

Other devices from Jiangsu Micsafe Medical Tehcnology Co., LTD.

  • micsafe 1

    Class II

  • Bial 1

    Class II

  • Mj 1

    Class II

  • Dispomed 1

    Class II

See all devices from Jiangsu Micsafe Medical Tehcnology Co., LTD. →

Properties

  • Supplied sterile
  • Single use
  • Administering medicine
  • Measuring function
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (16, all answered No)