Opitek International
Active in EUDAMEDDenmarkfrom SRN EUDAMED SRN DK-MF-000001594
- Devices
- 24
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
Catalogue
Hip Fix 1900. Complete system with fixed pads Ref 1900-01
Lift string, upholstered, single use Ref 2006-50
Velcro fastener, round, single use, 50 pcs./pack Ref 2006-65
Lift string set w/ 2 strings, single use Ref 2006-70
Lift string, velcro, single use Ref 2006-60
Leg & Arm Lift, electrical, complete system Ref 2009-01
Lift string, wide, upholstered, 1 pcs., single use Ref 2006-70-1
Company details
- EUDAMED SRN
- DK-MF-000001594
- EU VAT number
- 1013408374
- EUDAMED status
- Active
- EUDAMED registered name
- Opitek International
- Registered address
- 252, Gøngehusvej, 2950, Vedbæk, Denmark
- Website
- opitek-international.dk/
- linkedin.com/company/369920
- [email protected]
- Phone
- +4539661644
- PRRC contact
- Peter Christensen
From the company website
At Mediplast we have a unique strategy to offer comprehensive health care solutions. Through close cooperation with leading suppliers and our own production opportunities, we ensure that we deliver the highest quality products and services, adapted to the specific needs of caregivers.
What Opitek International makes
Opitek International manufactures single-use and reusable positioning systems for surgical procedures, including modular hip fixation systems with adjustable and fixed pads, upholstered lift strings, and support cushions. Their portfolio also includes Velcro fixation straps for pediatric stirrup shoes and complete lateral positioning systems for patient stabilization during surgery.
The company’s devices fall under Class I medical device classification and are listed in the EUDAMED registry. Opitek International is based in Denmark.
Frequently asked questions
How many devices does Opitek International have in the registry?
The registry currently lists 24 devices for Opitek International. Devices recorded under merged duplicate company entries are counted once.
Which registries list Opitek International's devices?
Among its 24 most recently registered devices, Opitek International has devices listed in EUDAMED (24 devices).
What risk classes do Opitek International's devices fall under?
Among its 24 most recently registered devices, the classes recorded for Opitek International's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Opitek International in the registry?
The most recently registered devices listed for Opitek International include Hip Fix 2015, Bariatric, Upgrade System. For single use pads, 2015-50-1, Hip Fix 1915, Complete System. For single use pads, 2015-50-1, Hip Fix 1900. Complete system with fixed pads and Lift string, upholstered, single use.