N/A MXL3-Bulb

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number20888937907777 UDI-DI	Date22 Aug 2016Listed	StatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic Name: Assisted reproduction microtool
Model / Reference: MXL3-BULB

Primary DI / UDI-DI: 20888937907777
510(k) Number: K993699
FDA Product Code: MQH
GMDN Term: Assisted reproduction microtool

Device Class: Class II
Regulation Number: 884.6130
GUDID distribution status: In Commercial Distribution

Other devices from Origio Inc.

N/A Mph-Med-45

Class II
N/A Mbb-Fp-Sm-20

Class II
Cryopette Cry-Pette-Gold

Class II
N/A Mdp-140-0

Class II
N/A MICC014-30-B1.0

Class II
N/A Mic-50-25

Class II

See all devices from Origio Inc. →

Properties

Single Use
Prescription Use

Other properties (12)

Sterile: No
Implantable: No
Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Lot / Batch Number: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No