Market
A common newborn finding
About 25% of newborns show an ear-shape difference at birth. Some settle in the first 10 days. About 3–5% have a remaining deformity that can be moulded in clinic — before later otoplasty enters the picture.
Global distribution · Partnership
Bring CranioWell to your country.
Exclusive regional distribution of a Class 1, physician-applied infant ear-molding set. Train with our videos, or come to our Ankara centre when you are in Türkiye.
Submit a partnership enquiryThe market
A common finding, one focused product.
Shift in care
Early molding, not school-age surgery
Pediatric care is moving from waiting for otoplasty toward a physician-applied option in the first weeks, while cartilage is still soft.
Supply
Recurring clinic demand
Each treated infant uses a single-patient, non-sterile kit. Clinic adoption creates ongoing demand for application sets and components.
Partnership
What we offer international distributors.
About 25% of newborns show an ear-shape difference at birth. Some of these settle in the first 10 days. Deformities that remain — about 3–5% of newborns — typically will not self-correct without intervention. Partners put a physician-applied option in the clinics that already see these infants.
Territorial exclusivity
Defined country or regional exclusivity for qualified distribution partners.
Regulatory and quality pack
Technical documentation, CE / ÜTS / EUDAMED listing, ISO certificates, and clinical files for hospital and ministry submissions.
Training for your network
Application videos for the physicians you onboard, plus on-site training at our Hacettepe Teknokent centre when your team comes to Ankara.
Sales enablement
Clinical brochures, workshop decks, and parent-facing materials your field team can take into pediatrics, neonatology, ENT, and plastics.
How we train you
Training videos, or come to our centre in Türkiye.
Physicians and distribution partners who want to work with the set can start with our application videos, then join hands-on training at our Ankara centre when they travel to Türkiye.
Application training videos
Step-by-step modules cover examination, kit placement, follow-up, and how to brief families. We share these with doctors and distributors who apply to work with CranioWell.
On-site training in Ankara
When you come to our centre at Hacettepe Teknokent, we train you and your clinical or field team in person — the same pathway we use with partner clinics today.
Ideal partner
Who this is for.
We look for distributors who already speak to the doctors who see newborns first — and who will train those clinics, not only stock the kit.
The right specialties
An established network in pediatrics, neonatology, ENT (otolaryngology), or plastic and craniofacial surgery.
Field and clinical support
A team that can reach hospital networks and private clinics, and stay with accounts after the first training.
Local physician training
Willingness to run local workshops — using our videos first, then sending key doctors or trainers to our Ankara centre.
Around the world
Already used in five countries. Needed in many more.
Physicians apply the Baby Ear Shape Corrector Set in Türkiye, South Korea, Azerbaijan, Greece, and Estonia. Having this option in your country can matter for every baby whose ear can still be moulded.
TürkiyeSouth KoreaAzerbaijanGreeceEstonia
We want children everywhere to reach a natural ear form without otoplasty — and without the surgical and anaesthesia risks of a later operation. A visible ear difference can also lead to teasing and bullying as a child grows. Early, physician-applied molding can change that path.
Instead of later surgery
When molding starts in the first weeks, many infants never need otoplasty. That can reduce exposure to anaesthesia and operative complications.
Before teasing starts
Prominent or folded ears can draw comments and bullying at school age. Correcting form in infancy can spare a child years of social pressure.
In your country
The first-month window is short. A trained physician nearby is more useful than a later flight for surgery. Ask us about training or distribution where you live.
Global network
Partners and clinics by country.
Country partners on the left. Treating physicians on the right — browse the short list, then open the full directory when you need more.
Estonia
Provider · Tallinn
Hansa Medical
Hansa Medical OÜ
Kadaka tee 131/5, 12915 Tallinn, Estonia
Greece
Provider · Athens
GETREMED
GETREMED Ltd
Anapafseos 6, Mets, 11636 Athens, Greece
Treating physicians
Doctors who apply the set
A short rotating list. Browse for more providers, or open the full directory.
Ankara / Türkiye
Uz. Dr. Yaşar Hüseyin Onganlar
Beytepe Mah. Kanuni Sultan Süleyman Bulvarı, 5345. Sokak No:2, 06800 Çankaya/Ankara
Baku / Azerbaijan
Uzm. Dr. Emiliya Efendiyeva
Baku Medical Plaza, Babek branch, Babək prospekti 92 N, Baku
Seoul / South Korea
Dr. Jihee Kim
Leauetlavie Co.
4th floor, 118 Bangbae-ro, Seocho-gu, 06664 Seoul, South Korea
Results
Before and after, from treating physicians.
English clinical cards from CranioWell doctors. Each case was applied and followed in clinic — not at home. Individual results vary with age at start and deformity type.
Dr. Ahmet Kurt
Malatya / Türkiye
Dr. Hikmet Çilli
Gaziantep / Türkiye
Dr. Emilya Efendiyeva
Azerbaijan / Azerbaijan
Quality
Certificates you can open and check.
ISO 13485 for medical-device quality, plus 9001, 14001 and 45001 — issued to CranioWell Medikal at Hacettepe Teknokent, Ankara.
ISO 13485:2016
Medical devices — quality management
QMS for the manufacture of orthopedic and related medical products. Certificate no. WRC-CRN-ISO-13485-TR/EN. Valid through 30 September 2026.
Open PDF
ISO 9001:2015
Quality management system
Production, import and export of medical, biomedical, orthopedic and surgical materials. CAS no. MS.0750.1488. Valid through 12 September 2026.
Open PDF
ISO 14001:2015
Environmental management
Environmental management system for the same medical manufacturing scope. FQC no. 14.24.12158.20498.I. Valid through 29 August 2026.
Open PDF
ISO 45001:2018
Occupational health and safety
OH&S management system for medical manufacturing. FQC no. 45.24.12158.30660.I. Valid through 29 August 2026.
Open PDF
Partnership enquiry
Tell us the territory you want to cover
The set is already in Türkiye, South Korea, Azerbaijan, Greece, and Estonia. If it is not yet in your country, we will follow up on exclusivity, supply, training videos, and an on-site workshop at our Ankara centre.
Are you a physician? Become a provider insteadCertifications & compliance
What buyers and partners can verify.
Class 1 medical device. CE marked. Quality system and national / EU device listings for hospital and ministry files.
- Device class
- Class 1 Medical Device
- CE
- CE marked
- Quality
- ISO 13485:2016 (also ISO 9001, 14001, 45001)
- ÜTS
- Listed in Türkiye ÜTS (medical device registration)
- EUDAMED
- Listed in EUDAMED (EU medical device database)
Certificates (ISO PDFs) are available on the Certificates page. Patent registered with the Turkish Patent and Trademark Office. Origin: Hacettepe Teknokent, Ankara.
View certificates