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Device Explorer · FDA GUDID · GMDN 40895

Vacuum-mould patient positioning system

An assembly of devices designed to apply a vacuum to a cushion or bag filled with foam-like material that is placed under, on, or around a patients body parts. A vacuum is applied to the contents of the cushion forming a patient specific (custom-made) mould. T

US‑registered devices427in commercial distribution
Companies11labelers on GUDID
Single‑use3%of device records
Sterile0%labelled sterile
Prescription43%Rx‑only share
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Share of device records

Klarity Medical Products, Llc20548%
3C-Medical Intelligence Gmbh7117%
Medtec, Inc.6515%
Izi Medical Products, Llc338%
Qfix235%
Macromedics B.V.235%
Guangdong Meicen Medical Equipment Co., Ltd.20%
Orfit Industries Nv20%

Top labelers

CompanyDevicesShare
Klarity Medical Products, Llc20548%
3C-Medical Intelligence Gmbh7117%
Medtec, Inc.6515%
Izi Medical Products, Llc338%
Qfix235%
Macromedics B.V.235%
Guangdong Meicen Medical Equipment Co., Ltd.20%
Orfit Industries Nv20%
Domico Med-Device, Llc10%
Cdr Systems Inc10%
Talon10%

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

Brand names on the register (sample)

MeicenOrfitBodyFIXVac-Lok™ CushionClam-Lok™ CushionRespiratory Plate Cushion KitRespiratory Plate CushionVac-Lok™ Vacuum CompressorHelping Hands ™KLARITY MEDICALKlarity MedicalVacuum BagTrueFormNAVacuum LockVacFix Pump

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, Medical368
IYEAccelerator, linear, medical139
JAICouch, radiation therapy, powered113
LNHSystem, nuclear magnetic resonance imaging70
JAICouch, Radiation Therapy, Powered10
IXQTable, radiographic, stationary top3

GMDN & GCC registration

  • GMDN code 40895 · non‑implantable
  • Single‑use 3% · sterile 0% · Rx‑only 43% · OTC 1%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Width (Centimeter) · 141Length (Centimeter) · 140Total Volume (Liter) · 100Length (Inch) · 6Length (Millimeter) · 1

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

How many vacuum-mould patient positioning system products are registered in the US?

427 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Vacuum-mould patient positioning system", from 11 companies. The largest labeler is Klarity Medical Products, Llc with 48% of records.

Which FDA product codes apply?

IYE (Accelerator, Linear, Medical), IYE (Accelerator, linear, medical), JAI (Couch, radiation therapy, powered), LNH (System, nuclear magnetic resonance imaging)

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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