Skip to content

Mico one

by Ze Fang Technology Co., Ltd. EUDAMED510(k)GUDID

Active United States and European Union

Ref L1-M-002244, L1-M-002234, W1-SS-011825, L1-M-002242, W1-NT-001600, L1-M-002243, W1-SS-011925, W1-SS-111825, L1-M-002225, W1-NT-001800, L1-M-002235, L1-M-002233, W1-NT-101200, W1-SS-111822, W1-NT-101400, W1-SS-111722, W1-NT-001200, W1-SS-011822, W1-SS-011622, L1-M-002232, W1-SS-111922, W1-NT-101600510(k) K202163

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number04719882854194 UDI-DIDate18 May 2026ListedStatusIn distribution
European UnionCE/MDD EUDAMED NumberB-04719882854194 Basic UDI-DIDate6 Mar 2025RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK202163 Date7 Oct 2022ClearedStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDD Expiring

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.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 24 Oct 2026.

Specification

EUDAMED · 510(k) · GUDID

Trade Name
Mico one EUDAMED
Mico One Orthodontic Wire GUDID
Mico One Orthodontic Bracket GUDID
Generic Name
Orthodontic archwire
Orthodontic bracket, metal
Model / Reference
L1-M-002244, L1-M-002234, W1-SS-011825, L1-M-002242, W1-NT-001600, L1-M-002243, W1-SS-011925, W1-SS-111825, L1-M-002225, W1-NT-001800, L1-M-002235, L1-M-002233, W1-NT-101200, W1-SS-111822, W1-NT-101400, W1-SS-111722, W1-NT-001200, W1-SS-011822, W1-SS-011622, L1-M-002232, W1-SS-111922, W1-NT-101600, W1-SS111722
Primary DI / UDI-DI
04719882854194, 04719882854149, 04719882858635, 04719882854170, 04719882858499, 04719882854187, 04719882858673, 04719882858642, 04719882854101, 04719882858512, 04719882854156, 04719882854132, 04719882858468, 04719882858628, 04719882858482, 04719882858581, 04719882858451, 04719882858611, 04719882858550, 04719882854125, 04719882858666, 04719882858505, 04719882856082, 04719882856075, 04719882856068, 04719882856044, 04719882856037, 04719882856020, 04719882856013, 04719882855993
Basic UDI-DI
B-04719882854194, B-04719882854149, B-04719882858635, B-04719882854170, B-04719882858499, B-04719882854187, B-04719882858673, B-04719882858642, B-04719882854101, B-04719882858512, B-04719882854156, B-04719882854132, B-04719882858468, B-04719882858628, B-04719882858482, B-04719882858581, B-04719882858451, B-04719882858611, B-04719882858550, B-04719882854125, B-04719882858666, B-04719882858505
510(k) Number
FDA Product Code
OAT 510(k)
DZC GUDID
EJF GUDID
EMDN Code
Q010403 Orthodontic brackets and buttons
GMDN Term
Orthodontic archwire
Orthodontic bracket, metal
Device Class
Class IIa EUDAMED
Class II 510(k)
Class I GUDID
Regulation
21 CFR Part 872.3640 510(k)
872.5410 GUDID
Market of Registration
Italy
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent
Commercial Distribution
In Commercial Distribution

Truth per registry

3 sources · 3 fields differ

FieldEUDAMED510(k)GUDID
FDA Product CodeEUDAMED
n/a
510(k)
OAT
GUDID
DZC
EJF
Device ClassEUDAMED
Class IIa
510(k)
Class II
GUDID
Class I
Regulation NumberEUDAMED
n/a
510(k)
872.3640
GUDID
872.5410

Manufacturer details

EUDAMED SRN
TW-MF-000016035
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Related devices

Category: Orthodontic tube

Other devices from Ze Fang Technology Co., Ltd.

See all devices from Ze Fang Technology Co., Ltd. →

Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (17)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No