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micsafe 1

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

Ref ISY05F30516Model 0.5ml 30*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-06971911296520), cleared under FDA 510(k) K202570 on 2 Jul 2021 and listed in FDA GUDID since 31 May 2023 (UDI-DI 06971911296520), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K202570

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-06971911296520 Basic UDI-DI 06971911296520UDI-DIDate18 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06971911296520 UDI-DI Date31 May 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK202570 Date2 Jul 2021DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-06971911296520 registered 18 May 2026 Active
  • FDA 510(k) K202570 decided 2 Jul 2021 Active
  • FDA GUDID UDI-DI 06971911296520 listed 31 May 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K202570
  2. Listed FDA GUDID 06971911296520
  3. Registered EUDAMED B-06971911296520

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Syringe for Insulin EUDAMED
micsafe GUDID
Generic name
Insulin syringe/needle, basic
Model / reference
0.5ml 30*5/16” EUDAMED
ISY05F30516 EUDAMED
1 GUDID
Primary DI / UDI-DI
06971911296520
Basic UDI-DI
B-06971911296520
510(k) Number
FDA product code
FMI, 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
880.5570, 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 30*5/16”
ISY05F30516
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

Cleared under the same submission (K202570)

and 8 more cleared under K202570

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
  • Manufacturing date
Other properties (15, all answered No)