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Device Explorer · FDA GUDID · GMDN 40896

Patient positioning thermoplastic mould material

A thermoplastic material used to create moulds of a patient's body. It is commonly supplied as sheets or meshes of thermoplastic material that have been coated with polyurethane for ease of handling and positioning. Most of these materials are softened by heat

US‑registered devices863in commercial distribution
Companies11labelers on GUDID
Single‑use41%of device records
Sterile0%labelled sterile
Prescription43%Rx‑only share
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Share of device records

Klarity Medical Products, Llc39946%
Qfix17921%
Medtec, Inc.13215%
Izi Medical Products, Llc587%
Macromedics B.V.445%
Guangdong Meicen Medical Equipment Co., Ltd.395%
Aktina Corp.51%
Cdr Systems Inc30%

Top labelers

CompanyDevicesShare
Klarity Medical Products, Llc39946%
Qfix17921%
Medtec, Inc.13215%
Izi Medical Products, Llc587%
Macromedics B.V.445%
Guangdong Meicen Medical Equipment Co., Ltd.395%
Aktina Corp.51%
Cdr Systems Inc30%
Dentis Co. ,Ltd20%
Blessing Cathay Corporation10%
Touchpoint Medical, Inc.10%

Company = labeler of record on GUDID. 11 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

MeicenAquaCast MaskFibreplastDual Hand / Shoulder Extremity FibreplastFoot Extremity FibreplastKnee / Elbow Extremity FibreplastSingle Hand Extremity FibreplastIntegraBiteEncompass™Thermoplastic Chin StrapProForm™ Pediatric ThermoplasticProForm™ ThermoplasticSolstice™ Shoulder ThermoplasticType-S™ ThermoplasticThermoplasticThermoplastic Frame

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

FDA product codes

CodeNameDevices
IYEAccelerator, linear, medical1,153
IYEAccelerator, Linear, Medical481
LNHSystem, nuclear magnetic resonance imaging167
ILHSplint, Hand, And Components65
IWEMonitor, Patient Position, Light-Beam35
LNHSystem, Nuclear Magnetic Resonance Imaging21

GMDN & GCC registration

  • GMDN code 40896 · non‑implantable
  • Single‑use 41% · sterile 0% · Rx‑only 43% · 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

Depth (Millimeter) · 978Length (Inch) · 134Width (Inch) · 128Width (Centimeter) · 117Length (Centimeter) · 37

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

How many patient positioning thermoplastic mould material products are registered in the US?

863 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Patient positioning thermoplastic mould material", from 11 companies. The largest labeler is Klarity Medical Products, Llc with 46% of records.

Which FDA product codes apply?

IYE (Accelerator, linear, medical), IYE (Accelerator, Linear, Medical), LNH (System, nuclear magnetic resonance imaging), ILH (Splint, Hand, And Components)

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.

How do I get quotes?

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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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