Skip to content

CT37stax

by Planer Limited

Ref GDCT37-MModel CT37stax

CT37stax (GDCT37-M) is an assisted reproduction heater/incubator (EU MDD Class IIa; FDA Class II; FDA product code PUB, Accessory, Assisted Reproduction, Exempt) made by Planer Limited, registered in EUDAMED on 15 Aug 2022 (Basic UDI-DI B-B199GDCT37M60) and listed in FDA GUDID since 3 Apr 2018 (UDI-DI B199GDCT37M60), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-B199GDCT37M60 Basic UDI-DI B199GDCT37M60UDI-DIDate15 Aug 2022RegisteredStatusActive
United StatesGUDID listing GUDID NumberB199GDCT37M60 UDI-DI Date3 Apr 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-B199GDCT37M60 registered 15 Aug 2022 Active
  • FDA GUDID UDI-DI B199GDCT37M60 listed 3 Apr 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID B199GDCT37M60
  2. Registered EUDAMED B-B199GDCT37M60

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
CT37stax EUDAMED
CT37 Incubator GUDID
Generic name
Assisted reproduction heater/incubator
Device name
CT37stax Benchtop Incubator
Model / reference
CT37stax, GDCT37-M, GDCT37-M-6
Primary DI / UDI-DI
B199GDCT37M60, B199GDCT37M0
Basic UDI-DI
B-B199GDCT37M60
FDA product code
PUB
EMDN code
U080299 Devices for assisted reproduction - other
GMDN term
Assisted reproduction heater/incubator
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
884.6120
System or procedure pack
System which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Romania
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

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
GB-MF-000002773
Authorised representative
Advena Limited MT-AR-000000234

Related devices

Category: Assisted reproduction vitrification carrier

Similar devices in this category

Other devices filed under DEVICES FOR ASSISTED REPRODUCTION - OTHER.

Other devices from Planer Limited

See all devices from Planer Limited →

Properties

  • Premarket exempt
Other properties (22, all answered No)