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Cryolock

by Biotech Inc

Ref CL-R-CT

Cryolock (CL-R-CT) is an assisted reproduction vitrification carrier (EU MDR Class IIa; FDA Class II; FDA product code MQK, Labware, Assisted Reproduction) made by Biotech Inc, registered in EUDAMED on 28 Oct 2022 (Basic UDI-DI ++B056CRYOLOCKFAMILYDEVW8), cleared under FDA 510(k) K122982 on 9 Jan 2014 and listed in FDA GUDID since 13 Dec 2016 (UDI-DI +B056CLRCT), active (EUDAMED, FDA 510(k)), not in commercial distribution (GUDID) as of 25 Oct 2026.

Active European Union and United States. Also listed in GUDID (US), not in commercial distribution.

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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K122982↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++B056CRYOLOCKFAMILYDEVW8 Basic UDI-DI +B056CLRCTUDI-DIDate28 Oct 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number+B056CLRCT UDI-DI Date13 Dec 2016ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k) 510(k) NumberK122982 Date9 Jan 2014IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI ++B056CRYOLOCKFAMILYDEVW8 registered 28 Oct 2022 Active
  • FDA 510(k) K122982 decided 9 Jan 2014 Active
  • FDA GUDID UDI-DI +B056CLRCT listed 13 Dec 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K122982
  2. Listed FDA GUDID +B056CLRCT
  3. Registered EUDAMED ++B056CRYOLOCKFAMILYDEVW8

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Generic name
Assisted reproduction vitrification carrier
Model / Ref / Catalog
CL-R-CT
Primary DI / UDI-DI
+B056CLRCT EUDAMED
B056CLRCT1 GUDID
Basic UDI-DI
++B056CRYOLOCKFAMILYDEVW8
Unit of use DI
1
510(k) Number
FDA product code
MQK
EMDN code
U08020401 Cryopreservation containers/straws/vials for assisted reproduction
GMDN term
Assisted reproduction vitrification carrier
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
884.6160
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
Not in Commercial Distribution
Sterilisation method
Radiation Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
+B056CLRCT
GUDID
B056CLRCT1
Device classEUDAMED
Class IIa
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists +B056CLRCT; FDA GUDID lists B056CLRCT1), so their flags are not compared. Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
US-MF-000002378
Authorised representative
Atlantico Systems, Ltd. IE-AR-000000208

Similar devices in this category

Other devices filed under CRYOPRESERVATION CONTAINERS/STRAWS/VIALS FOR ASSISTED REPRODUCTION.

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 (19, all answered No)