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micsafe 1

by Jiangsu Micsafe Medical Tehcnology Co., LTD. 24 variants

micsafe 1 is a blood collection tube holder/needle (FDA Class II) made by Jiangsu Micsafe Medical Tehcnology Co., LTD., cleared under FDA 510(k) K212019 on 4 Nov 2021 and listed in FDA GUDID since 31 May 2023 (UDI-DI 06971911291501), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K212019

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06971911291501 UDI-DI Date31 May 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK212019 Date4 Nov 2021IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K212019 decided 4 Nov 2021 Active
  • FDA GUDID UDI-DI 06971911291501 listed 31 May 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K212019
  2. Listed FDA GUDID 06971911291501

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
micsafe
Generic name
Blood collection tube holder/needle
Model / reference
1
Primary DI / UDI-DI
06971911291501
510(k) Number
FDA product code
FMI, FMF, MEG
GMDN term
Blood collection tube holder/needle
Device class
Class II
Regulation number
880.5570, 880.5860
GUDID distribution status
In Commercial Distribution

Related devices

Category: Blood collection tube holder/needle

Cleared under the same submission (K212019)

and 5 more cleared under K212019

Similar devices

Other devices filed under FDA product code FMI (Needle, Hypodermic, Single Lumen).

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
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)