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Device Explorer · FDA GUDID · GMDN 62068

Ex vivo cell culture medium

A solution used for the ex-vivo culture of human-derived or non-human cells [e.g., T-lymphocytes, mesenchymal stem cells (MSCs), embryonic stem cells, induced pluripotent stem cells (iPSC)] or immortalised cell lines (e.g., HaCat, HeLa, HEK-293, cos-7, PC-12)

US‑registered devices1,077in commercial distribution
Companies4labelers on GUDID
Single‑use3%of device records
Sterile41%labelled sterile
Prescription0%Rx‑only share
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Share of device records

Lonza Verviers77372%
Lonza Walkersville, Inc.22221%
Expression Systems, Llc525%
Intermountain Life Sciences, Llc303%

Top labelers

CompanyDevicesShare
Lonza Verviers77372%
Lonza Walkersville, Inc.22221%
Expression Systems, Llc525%
Intermountain Life Sciences, Llc303%

Company = labeler of record on GUDID. 4 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

GLS Feed Base N, 100LBulk Packaged ster. filtered WFI - 1LGLS Lonza Medium Base 1 - 10kgmRNA Buffer 113 : 200L BagmRNA Buffer 113 : 1L Bag samplemRNA Buffer 112 : 1L Bag samplemRNA Buffer 112 : 200L BagmRNA Buffer 103 : 200L BagmRNA Buffer 103 : 1L Bag sampleBuffer L AP-5 : 500L BagBuffer L AP-5 : 1L Bag sampleBuffer S30-2: T-25 SUO-001: 1L bag samplBuffer S30-2: T-25 SUO-001 - 1000L BagBuffer D:T-19 SUO-001 Module L 1000L BagBuffer U: T-18 SUO-001 Module L 1L BagBuffer U: T-18 SUO-001 Module L 500L Bag

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

FDA product codes

CodeNameDevices
KITMedia And Components, Synthetic Cell And Tissue Culture660
PPMGeneral Purpose Reagent226
JSKSupplement, Culture Media134
NDSMEDIA, CULTURE, EX VIVO, TISSUE AND CELL38
KIPFormulations, Balanced Salt Solutions28
JCFLymphocyte Separation Medium22

GMDN & GCC registration

  • GMDN code 62068 · non‑implantable
  • Single‑use 3% · sterile 41% · Rx‑only 0% · OTC 5%
  • 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.

No closely related category with 50+ devices.

How many ex vivo cell culture medium products are registered in the US?

1,077 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Ex vivo cell culture medium", from 4 companies. The largest labeler is Lonza Verviers with 72% of records.

Which FDA product codes apply?

KIT (Media And Components, Synthetic Cell And Tissue Culture), PPM (General Purpose Reagent), JSK (Supplement, Culture Media), NDS (MEDIA, CULTURE, EX VIVO, TISSUE AND CELL)

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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