Ottobock Manufacturing Bulgaria EOOD

FDA Device Registration & Listing · Blagoevgrad, BG · Registration 3018070833

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3018070833
FEI Number
3018070833
Entity Name
Ottobock Manufacturing Bulgaria EOOD
City/State/Country
Blagoevgrad, BG
Establishment Address
36 Vasil Levski Blvd., Blagoevgrad 2700, BG
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Ottobock SE & Co. KGaA (Owner Number: 8010097)
Owner / Operator Contact Address
Max-Naeder-Strasse 15, Duderstadt, DE-NI 37115, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Dorso Osteo Care Spinal Orthosis Lumbo Direxa Stable Lumbo Sensa, women Spine Sport Dosi EQ X Multi 627, 631, 637 Lumbo Sensa Lumbo Direxa Woman Dorso Direxa Posture Dorso Carezza Posture Lumbo Carezza Lumbo Direxa High Dyneva Dorso Direxa Basic Dyneva light Hyperextension orthosis Hyperextension brace Lumbo Tristep Lumbo Direxa Tube-Adap,Short-34mm Steel Definitiv-Sportadapter TT Sliding Adapter ProCarve Foot Standard Tube-Adapter, Children Double Adaptor w. Screws Sprinter Terion K2 Adjust Taleo Side Flex Renegade AT Foot for water resistant prothesis Tube-Adap,Long-34mm-Steel Meridium Runner Footshell for 1M10 Foot Adapter-Titan- Anprobe-Sportadapter TT Kintrol Bionic-Foot Footshell Sliding Adapter -Titanium- Maverick VS Connection Cap Trias Footshell Footshell Gen2 High Tube Adapter, long, 34 mm, Titanium TF Test-Sportfootadapter Sliding Plate hole plate Dynamic Plus Prosthetic Foot Dynamic Motion Prosthetic Foot Tube-Adapter, short Tube Adaptor Aluminium Short Shaped Ankle Block Tube Adaptor, long, Aluminum Spherical Sliding Adapter Runway HX Triton Side Flex Tube Adaptor, angular 10 degrees, 20 degrees, 30 degrees, Titanium Runway C-Walk Sprinter Junior Defender Foot Adapter with thread Tube Clamp Adaptor-Alum. Terion SACH Foot,Child Complete bolt assembly Axtion Triton Vertical Shock Cosmetic Light Foot with Toes Tube Adapter f. water resist. Prothesis DeltaTwist Runner junior Tube Adapter, angled, Children Connection Adapter Challenger Pirogoff Foot Lo Rider Triton LP Bk Kit-34mm-Clamp-Titanium Tube Adapter, short, 34 mm, Titanium TF Sports Foot Adapter Socket Att.Block Mod.F.Ch Dynamic Ft,Women,20mm,Toes Footshell 1C40 Runner Sole Maverick Comfort AT Maverick Junior Foot Shell Gen2 Single Axis Adapter Runner junior Pyramid Adapter, rotatable Foot Shell Kintrol Maverick Junior Footshell LP Symes Footshell Runway HX Sandal Tube Adaptor,Short,Titan Tube Clamp Adaptor, Titan Restore Single Axis Foot Only Men Tube Adaptor,Long,Titan Tube Adaptor, Angled, Titan 10 -20 -30 degrees Greissinger plus foot Otto Bock Dynamic Foot for children Evanto Bk Kit-34mm-Clamp-Steel Foot Shell Gen3 Footshell Runway Regular Single Axis Foot Adapter Foot Adapter Modular Transfemoral Kit Slide Clamp-Alum Footshell Runway Sandal Dynamic foot with toes Connection Cap for 2C1 small Slide Adap. With 4 Screw Conn Maverick Footshell ProSymes Prosthetic Foot Double Adapter with Pyramid Taleo SACH plus Foot Evanto Footshell Modular Transtibial Kit Freestyle Swim Footshell Runway HX Regular Footshell ProSymes Sole Kit 1E90 Sprinter - with Spikes Triton Maverick Xtreme AT Footshell-Child Tube-Adapter, long Tube Clamp Adapter Foots Shell Freestyle Swim Promenade Taleo Adjust Chopart Triton HD Footshell for 1C10 Trias Renegade LP-AT Taleo LP SACH-foot Sole Kit 1E90 Sprinter Axtion DP Triton Harmony Sliding Adaptor -Titanium- Taleo Footshell SACH Foot,Child,Medium Taleo VS, Taleo Harmony SACH Foot Threaded Valve With Housing Valve for Flexible Socket Vacuum connector Tube Valve for Suction Socket Harmony P3 One-way valve Harmony P4 HD Flat Rubber Valve ClickValve Mag Valve Valve for Isny Socket Push Valve Harmony P4 Vacuum Pump Socket Adapter - titanium - B.K. Socket Adapter-Titanium Socket Adaptor w. Adjustment Screws Klima-Arm Liner Knee Cap, reinforced Derma Seal forte Varos Liner Eingussanker, gew. Arm, JK Socket Adaptor with Rotation Pyramid Lamination Anchor Sock.Adpt. , Adjust.Screws Derma Seal Gel Socks Rotatable Sock.Adapt.Titan Lamination Ring up to 150 kg Socket Adapter - aluminium - Two-Directional Rubber Knee Cap Sock.Adapt.With Pyramid Titan Socket attachment block for thermoplast socket Sock.Adapt.With Adjust.Screws ProSeal Ring Socket Adapter w. Pyramid Socket Attachment Block Socket Adapt.with Pyramid Dynamic Vacuum System System-Extension Assist Socket Adaptor-Aluminum MagnoFlex Lock Shuttle Lock Double Adapter Rotatable 4 prong Adapter with adj screws Varos Lamination Anchor with angled arm Socket Adapter w. Rotation Adjustment lam. Anchor f. water resist. Prothesis Rotatable 4 prong Adapter with Pyramid Socket Adaptor-Child Socket Adapter Tube Clamp Adaptor Rotatable Socket Adaptor connectgo Lamination anchor for children AXON Tube Adapter Modular knee joints Eccentric Adapter -titanium - Polycntr. Knee for KD, Lock,Titan. Polycntr. Knee Joint for KD, Lock Tube Adapter with torsion unit, 34 mm Genium ProCarve knee joint Lock Lever Single Axis Knee Joint, Break Titan. USB Adapter for charging Modular Knee Joint, pneumatic Knee Joint Children, Lock Modular Friction Brake Knee Joint with Lock Modular Kneejoint, monocentric with hydraulic rotation and electrically controlled stand phase Single Axis Knee Joint Children Comfort Brake Knee pneumatic system Modular EBS Knee Joints Single Axis Knee Joint, Break Modular Knee Joint Modular Sports Knee Joint Prosedo C-Leg Tube Adapter with Torsion Unit Tube Clamp Adapter 34, INOX Mod. Polycentric Knee Joint Quickchange Genium X3 Torsion Adapter Polycntr. Knee Joint for KD Sliding adapter Kenevo Rotation Adapter Cockpit Adapter Plate C-Leg dynion explore Polycntr. Knee Joint for KD, Titan. AXON Tube Adapter with Torsion EBS-PRO-Knee Harmony E2 Battery Charger for C-Leg Tube Clamp Adapter 34, Titan Inductive Charger Single Axis Knee Joint, Lock Aqua Knee C-leg Tube Adapter Dynion Pyramid Adaptor with Internal Thread Children's knee joint Adapter Plate Harmony E2 Modular Knee Joint, servo-pneumatic Lightweight Knee Joint, Lock Lightweight Hydraulic Knee Pheon - Modular Knee Joint Polycntric Knee Joint, Children Genium X4 Single Axis Knee Joint, Lock, Titan. Polycntr. Hydr. Knee Joint, Titan. Modular Knee Joint with Rotary Hydraulic Adapter Ring Kenevo A-B-C Polycntr. Knee Joint, Titan. Wrist Splint Manu Immobil Manu Immobil Long Wristorthosis Manu Neurexa, Plus Hand night splint for 28P30 Syst.Cov.Bale Lock Jt.Hd. Swiss Lock Knee Joint for Child Lock lever extender for 17KL100 Medial Support for E-Mag Active Lim.Mot.Knee Joint f.Child Genu Direxa Syst.-Adj.Swiss Lock Knee Joint Syst.Ring Lock Joint Head E-Mag active Genu Immobil Vario T Genu Direxa Stable wraparound System Ring Lock Joint Head Free Mot. Kn.Jt.for Child. Genu Neurexa DTO - Diagnostic Trial Orthosis Posterior Off Set Free Knee Joint Xeleton Syst.-Free Motion Jt. Head Ring Lock Knee Joint for Child Genu Immobil Agilium SoftFit Knee Joints Manual Ring Lock Knee Joint Automatic Heavy Ring Lock Knee Joint Agilium Reactive Agilium Vantage Knee Joint f.Wood Prosth. Sys.-Cov.Bale Lock Jt.Hd. Genu Carezza Patella Stabilizer Genu Sensa Genu Direxa wraparound Syst.-Free Motion Jt.Head Patella Pro System-Covered Bale Lock Knee Joint Free Walk Orthoses Genu Direxa Stable System Knee Joint Plastic Polyc. Knee Joint Agilium Patella Free Motion Knee Joint Knee Joint f.Plast.Prosth. Syst.-Cov.Bale Lock Jt. Hd Manual Heavy Ring Lock Knee Joint C-Brace joint unit Knee joint bar Syst.-Cable Release Jt.Hd. Bow ,Chailey Kit C-Brace Setup Knee Orthosis Genu Arexa System Knee Joint with Lamination Set Bale Lock Knee Joint Knee Joint Agilium Freestep Automatic Ring Lock Knee Joint Agilium Forte System Wedge Lock Knee Joint Titanium Ring Lock Kn.Jt.for Child Bar Lock Knee Joint Polycentric Knee Joint 4-1 Option Lock Knee Joint Knee Bearing Joint Syst.-Polycentric Jt. Head Various models PRN Original Elbow Pad RX Elbow Sleeve X-RX Wrist Support X-RX Elbow Support RX Original Elbow Sleeve UD Tennis Elbow Sleeve Arm Abduction Orthosis Acro Assist Epi Forsa Plus UD Tennis Elbow Strap UD Hyper-X Elbow Brace QD Forearm Sleeve 1,5mm Pair Black PRN Elbow Pad QD Elbow Sleeve PRN Elbow Pad Jr Arm Abduction Orthosis, Dynamic QD Wrist & Thumb Support QD Shoulder Support UD X-Stable Shoulder Brace PRN Original Elbow Pad Jr FitKit WalkOn Lateral Junior FitKit WalkOn Lateral Heel wedges 10 degrees, 16 degrees, 22 degrees X-ible flexible ankle joints WalkOn Fit Kit Mulfifunction correction system joints WalkOn Flex Fit Kit Dual Function Ankle Joint Nexgear extension bars Multifunctional system ankle joint Infinity Air Walker, high System-toe Pick-up Ank.Jt. Malleo TriStep Ankle Orthosis Ankle Support Active Contour Ankle Joint Dyna Ankle - Dynamic Ankle Orthosis Concealed Spring Ankle Joint WalkOn Trimable Infinity Air Walker, low Malleo Neurexa System-Limit Mot Ankle Jt. WalkOn Reaction Malleo Sprint WalkOn Reaction Fit Kit WalkOn Reaction Plus Fit Kit Carbon Ankle Seven System Ankle Joint With Lam. Set Walk On Flex Malleo Immobil Night Splint FitKit WalkOn Reaction Lateral FitKit WalkOn Flex Junior Nexgear Tango Ankle Joint Nexgear side bar bilateral GoOn Achillo Sensa WalkOn Reaction Plus, Junior Malleo Sensa Heel wedges 15 degrees, 30 degrees Malleo Direxa Stirrup Unilateral Ankle Joint Walk-On AFO Medial joint for correction joint Reaction modul Foot stirrup WalkOn lateral Nexgear lamination bar bilateral WalkOn Reaction lateral Malleo Neurexa pro Heel Relief Orthosis Des. By Dr. Settner

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IQE Orthosis, Lumbar Physical Medicine Class 1 890.3490 2005-07-28
ISH Component, External, Limb, Ankle/Foot Physical Medicine Class 1 890.3420 2005-07-28
ISP Valve, Prosthesis Physical Medicine Class 1 890.3420 2014-11-03
ISS Prosthesis, Thigh Socket, External Component Physical Medicine Class 1 890.3420 2005-05-12
ISY Joint, Knee, External Limb Component Physical Medicine Class 1 890.3420 2005-07-28
ILH Splint, Hand, And Components Physical Medicine Class 1 890.3475 2014-05-05
ITQ Joint, Knee, External Brace Physical Medicine Class 1 890.3475 2014-05-05
KNN Components, Wheelchair Physical Medicine Class 1 890.3920 2003-12-11
IOY Support, Arm Physical Medicine Class 1 890.3475 2014-05-05
ITW Joint, Ankle, External Brace Physical Medicine Class 1 890.3475 2005-07-28

Official Correspondent

No official correspondent registered.

US Agent Details

Caleb Beck Business: Otto Bock HealthCare, LP Email: Caleb.Beck@ottobock.com Phone: (801) 9746647

Related Public Records

Same Entity

Ottobock SE & Co. KGaA
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3007923118 Otto Bock Mobility Solutions GmbH Koenigsee Thuringia, DE
9681725 Otto Bock Manufacturing Konigsee GmbH Koenigsee Thuringia, DE
3001917653 OTTO BOCK ITALIA SRL BUDRIO Bologna, IT
9611742 OTTO BOCK (CHINA) INDUSTRIES CO., LTD. BEIJING, CN
3005190268 Otto Bock Healthcare Products GmbH Vienna Wien, AT

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018070833. Last updated year: 2026. Please use registration number 3018070833 when referencing this establishment in official correspondence.
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