mHTF 15227

by Vitrolife AB

mHTF 15227 is a Class II device made by Vitrolife AB, cleared under FDA 510(k) K023655 on 13 Dec 2002 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00805360016551), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00805360016551 UDI-DI	Date23 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK023655	Date13 Dec 2002Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00805360016551
FDA 510(k) database 510(k) number K023655

Across registries

2 registries list this device

FDA 510(k) K023655 decided 13 Dec 2002 Active
FDA GUDID UDI-DI 00805360016551 listed 23 Sep 2016 Listed

Timeline

2 dated events

13 Dec 2002 Cleared FDA 510(k) K023655
23 Sep 2016 Listed FDA GUDID 00805360016551

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: mHTF
Generic name: Cell culture medium IVD
Model / reference: 15227

Primary DI / UDI-DI: 00805360016551
510(k) Number: K023655
FDA product code: MQL
GMDN term: Cell culture medium IVD

Device class: Class II
Regulation number: 884.6180
GUDID distribution status: In Commercial Distribution

Size: Total Volume — 500 Milliliter

Similar devices in this category

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Other devices from Vitrolife AB

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Properties

Supplied sterile
Single use
Prescription use
Lot / batch number
Expiration date

Other properties (10, all answered No)