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S-Cryolock (C) S-Cl (C)

by Biotech Inc

S-Cryolock (C) S-Cl (C) (S-CL (CLEAR)) is an assisted reproduction vitrification carrier (FDA Class II; FDA product code MQK, Labware, Assisted Reproduction) made by Biotech Inc, cleared under FDA 510(k) K122982 on 9 Jan 2014, registered in EUDAMED and listed in FDA GUDID since 26 Apr 2019 (UDI-DI B056SCLC1), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K122982

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID NumberB056SCLC1 UDI-DI Date26 Apr 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK122982 Date9 Jan 2014IssuedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K122982 decided 9 Jan 2014 Active
  • EUDAMED Active
  • FDA GUDID UDI-DI B056SCLC1 listed 26 Apr 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K122982
  2. Listed FDA GUDID B056SCLC1

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
S-Cryolock (C)
Generic name
Assisted reproduction vitrification carrier
Model / Ref / Catalog
S-CL (C), S-CL (CLEAR)
Primary DI / UDI-DI
B056SCLC1
510(k) Number
FDA product code
MQK
GMDN term
Assisted reproduction vitrification carrier
Device class
Class II
Regulation number
884.6160
GUDID distribution status
In Commercial Distribution
Sterilisation method
Radiation Sterilization

Related devices

Category: Assisted reproduction vitrification carrier

Cleared under the same submission (K122982)

and 8 more cleared under K122982

Similar devices in this category

Other devices filed under Assisted reproduction vitrification carrier.

Other devices from Biotech Inc

See all devices from Biotech Inc →

Properties

  • Supplied sterile
  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)