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EmbryoGen & BlastGen 12062003D

by Origio A/S

EmbryoGen & BlastGen 12062003D is an IVF medium kit (FDA Class II; FDA product code MQL, Media, Reproductive) made by Origio A/S, cleared under FDA 510(k) K152932 on 29 Feb 2016 and listed in FDA GUDID since 28 Mar 2017 (UDI-DI 60888937819832), active as of 23 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 23 Oct 2026

Documents

510(k) K152932

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number60888937819832 UDI-DI Date28 Mar 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK152932 Date29 Feb 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K152932 decided 29 Feb 2016 Active
  • FDA GUDID UDI-DI 60888937819832 listed 28 Mar 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K152932
  2. Listed FDA GUDID 60888937819832

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
EmbryoGen & BlastGen
Generic name
IVF medium kit
Model / reference
12062003D
Primary DI / UDI-DI
60888937819832
510(k) Number
FDA product code
MQL
GMDN term
IVF medium kit
Device class
Class II
Regulation number
884.6180
GUDID distribution status
In Commercial Distribution

Related devices

Category: IVF medium kit

Cleared under the same submission (K152932)

Similar devices

Other devices filed under FDA product code MQL (Media, Reproductive).

Other devices from Origio A/S

See all devices from Origio A/S →

Properties

  • Supplied sterile
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)