Manufacturer

Ортотех ООД

Bulgaria

Markets : Bulgaria

Approvals : EU – class I

4 categories, 83 models including 83 on the market, 1 country

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Thoracolumbosacral spine orthoses	Y060309	3/4 Silicone insoles3 refs Ankle Brace Comfort3 refs Ankle Brace Extra3 refs Ankle Brace Light3 refs Ankle Brace Standard3 refs 31 others Ankle Positioning Orthosis Fix3 refs Frejka Pillow Kids3 refs Hallux Ligth Toe Separators2 refs Hallux Protect Duo Toe Separators Hallux Protect Toe Separators Hallux Rings Toe Separators3 refs Hallux Valgus Brace Knee Brace Comfort2 refs Knee Brace Comfort Plus3 refs Knee Brace Extra3 refs Knee Brace Fix3 refs Knee Brace Fix Uni Knee Brace Kids3 refs Knee Brace Long Knee Brace Short Knee Brace Standard3 refs Knee Brace Standard plus3 refs Knee Brace UNI Little Toe Protector Madame silicone insoles3 refs Multi-centric Knee Brace Fix4 refs Patellabrace Comfort Pavlik Harness Kids3 refs Peroneal Brace Standard3 refs Shell Ankle Brace Standard Silicone Heel Pads with Soft Zone3 refs Silicone Heels Classic3 refs Silicone Insoles Classic3 refs Silicone Insoles with Soft Zones3 refs Supinators Kids3 refs Textile Toe Protector2 refs	I MDR	EUDAMED record Report an error
Sacroiliac spine orthoses	Y060303	Clalvicle Brace Fix Clalvicle Brace Kids Clavicle Brace Fix plus3 refs Clavicle Brace Kids PLlus Elbow Brace Comfort3 refs 23 others Elbow Brace Comfort Silico3 refs Epibrace Comfort Hand Orthosis Antispastic3 refs Hand Orthosis Standard II, III or IV Phalanges3 refs Hand Orthosis Standard V Phalanges3 refs Mitela Kids Mitela Light2 refs Mitela Light Ortho Shoulder Abduction Orthosis Extra 31207.U Shoulder Brace Light3 refs Shoulder Brace Standard3 refs Thumb and Forearm Orthosis Fix3 refs Thumb Orthosis Standard3 refs Thumb Stabilizer Light3 refs Upper limb orthosis Upper Limb Orthosis Fix2 refs Upper Limb Orthosis Kids Wrist and Forearm orthosis Wrist and Forearm Orthosis Extra 31603.1.L3 refs Wrist and Forearm Orthosis Kids2 refs Wrist and Forearm Orthosis Standard 31202.1.L3 refs Wrist Brace Light 31204.U Wrist Brace Light Plus 31601.U	I MDR	EUDAMED record Report an error
Thoracolumbar orthoses	Y060306	Abdominal Hernia Brace3 refs Abdominal Wall Brace Plus3 refs Back Brace Comfort3 refs Back Brace Extra3 refs Back Brace Extra Hessing3 refs 13 others Back Brace Extra Max3 refs Back Brace Light Elastic3 refs Back Brace Pregnancy Back Brace Standard3 refs Back Brace Standard Anatomic3 refs Back Brace Standard Basic 10116.1.B3 refs Back Brace Standard Mommy Chest Brace3 refs Chest/Abdominal Wall Brace3 refs DORSOFIX3 refs Inguinal hernia belt LUMBOFIX3 refs Stoma Support Brace3 refs	I MDR	EUDAMED record Report an error
Cervical spine orthoses	Y060312	Semi-rigid Cervical Collar Standard3 refs	I MDR	EUDAMED record Report an error

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