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Bioland E201

by Bioland Technology Ltd.

Bioland E201 is a Class II device made by Bioland Technology Ltd., cleared under FDA 510(k) K213011 on 5 Apr 2022 and listed in FDA GUDID since 14 Apr 2026 (UDI-DI 06939184620039), 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) K213011

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 Number06939184620039 UDI-DI Date14 Apr 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK213011 Date5 Apr 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K213011 decided 5 Apr 2022 Active
  • FDA GUDID UDI-DI 06939184620039 listed 14 Apr 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K213011
  2. Listed FDA GUDID 06939184620039

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Bioland
Generic name
Infrared patient thermometer, skin
Model / reference
E201
Primary DI / UDI-DI
06939184620039
510(k) Number
FDA product code
FLL
GMDN term
Infrared patient thermometer, skin
Device class
Class II
Regulation number
880.2910
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Similar devices

Other devices filed under FDA product code FLL (Continuous Measurement Thermometer).

Other devices from Bioland Technology Ltd.

See all devices from Bioland Technology Ltd. →

Properties

  • Serial number
  • Manufacturing date
Other properties (13, all answered No)