FDA Registration
Active
🇺🇸 United States
Blatchford, Inc.
Reg #: 1058311
·
FEI: 1000307649
·
Expires 2026
Products
5
Proprietary Names
50
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- Blatchford, Inc.
- Registration Number
- 1058311
- FEI Number
- 1000307649
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 1031 Byers Rd
- City
- Miamisburg
- State
- OH
- ZIP
- 45342
- Country
- US
Owner / Operator
- Firm Name
- Blatchford Inc dba Endolite.
- Operator Number
- 9011615
- Address
- 1031 Byers Rd, --
- City
- Miamisburg
- State
- OH
- Postal Code
- 45342
- Country
- US
- Correspondent
- Timothy Dues
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2023-08-14 |
| Joint, Knee, External Limb Component | ISY | Class 1 | Physical Medicine | No | 1994-10-07 |
| Component, External, Limb, Ankle/Foot | ISH | Class 1 | Physical Medicine | No | 1994-10-07 |
| Cover, Limb | IPM | Class 1 | Physical Medicine | No | 1994-10-07 |
| Joint, Hip, External Limb Component | ISL | Class 1 | Physical Medicine | No | 1994-10-07 |
Proprietary Names
Blatchford Digital Health App - Tectus
Tectus
Orion
Compact SAKL
KX06
ESK+
Smart IP
Aqualimb TF
Orion 3
EUK 160H
Linx
BMK2
Mercury
ESK+MKL
Male Pyramid Adapter
Proximal Adapter
Non-Rotating Pyramid Adapter
Avior
Female Pyramid Adapter
Avalon
EchelonVT
EliteVT
Elan
Multiflex
ElanIC
Dynamic Response 2
EchelonER
Stellar
Blade XT
Aqualimb
AvalonVAC
Epirus
EchelonVAC
Multiflex Ankle
TTPro
Echelon
Elite2
Mini Blade XT
Javelin
Super SACH
Elite Blade
Senior
Navigator
Elite BladeVT
Esprit
Silcare Active
Comfort Liner
Silcare Breathe
Silcare Breathe Active
4 Bar Hip
Establishment Types
Manufacture Medical Device