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Device Explorer · FDA GUDID · GMDN 40513

Ultralow-temperature laboratory freezer

A mains electricity (AC-powered) freezer designed for the storage of laboratory products and sample materials, e.g., in vitro diagnostic (IVD) reagents and laboratory tissue/body fluid samples that require extremely low temperatures, usually in the range from

US‑registered devices195in commercial distribution
Companies6labelers on GUDID
Single‑use1%of device records
Sterile0%labelled sterile
Prescription3%Rx‑only share
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Share of device records

Key Scientific Inc12564%
Qingdao Haier Biomedical Co Ltd2915%
Thermo Fisher Scientific (Asheville) Llc2211%
B Medical Systems Sarl84%
Thermogenesis Corp.63%
Helmer, Inc.53%

Top labelers

CompanyDevicesShare
Key Scientific Inc12564%
Qingdao Haier Biomedical Co Ltd2915%
Thermo Fisher Scientific (Asheville) Llc2211%
B Medical Systems Sarl84%
Thermogenesis Corp.63%
Helmer, Inc.53%

Company = labeler of record on GUDID. 6 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Haier BiomedicalHaierB Medical SystemsThermogenesis BioArchiveAuto Volume ExpressorImpulse Overwrap Bag Sealer 110vThermoGenesis Overwrap Bag Kit, 100ThermoGenesis CanistersBioArchive SystemFarrari.Series®Thermo Scientific ™VWRCardinalHealth™Isotemp™Thermo Scientific™ TSX™ Core Series Ultra-Low Te

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
KSERefrigerator, Freezer, Blood Storage194
JRMFreezer5
OAOCord Blood Processing System And Storage Container1
KSEREFRIGERATOR, FREEZER, BLOOD STORAGE1

GMDN & GCC registration

  • GMDN code 40513 · non‑implantable
  • Single‑use 1% · sterile 0% · Rx‑only 3% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

Use these as the dimensions to specify in a tender line.

How many ultralow-temperature laboratory freezer products are registered in the US?

195 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Ultralow-temperature laboratory freezer", from 6 companies. The largest labeler is Key Scientific Inc with 64% of records.

Which FDA product codes apply?

KSE (Refrigerator, Freezer, Blood Storage), JRM (Freezer), OAO (Cord Blood Processing System And Storage Container), KSE (REFRIGERATOR, FREEZER, BLOOD STORAGE)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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