FDA Registration
Active
🇩🇪 Germany
DARCO (Europe) GmbH
Reg #: 3006026111
·
FEI: 3006026111
·
Expires 2026
Products
6
Proprietary Names
30
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- DARCO (Europe) GmbH
- Registration Number
- 3006026111
- FEI Number
- 3006026111
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- GEWERBEGEBEIT 18
- City
- RAISTING Bavaria
- Country
- DE
Owner / Operator
- Firm Name
- DARCO INTERNATIONAL, INC.
- Operator Number
- 9001626
- Address
- 810 MEMORIAL BLVD., --
- City
- Huntington
- State
- WV
- Postal Code
- 25701
- Country
- US
- Correspondent
- MARK S COOPER
US Agent
- Business Name
- Darco International Inc.
- Contact Name
- Mark Cooper
- Address
- 810 Memorial Blvd. Huntington
- City
- Huntington
- State
- WV
- ZIP
- 25701
- Country
- US
- [email protected]
- Phone
- 304 5224883
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Rib Fracture, Soft | IPX | Class 1 | Physical Medicine | No | 2006-07-17 |
| Joint, Hip, External Brace | ITS | Class 1 | Physical Medicine | No | 2025-03-18 |
| Support, Arm | IOY | Class 1 | Physical Medicine | No | 2006-07-17 |
| Orthosis, Corrective Shoe | KNP | Class 1 | Physical Medicine | No | 2006-09-27 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2006-07-17 |
| Splint, Extremity, Inflatable, External | FZF | Class 1 | General, Plastic Surgery | No | 2007-03-19 |
Proprietary Names
MECRON Belt
MECRON Hip Spica
Mecron Elbow Splint
Mecrom Elbow Splint Pediatric
AllRound Shoe
Gentle Step
Wound Care Shoe
Duo Shoe
Heelwedge
Pogo Pulsus
Ultra Off Loading Shoe
Strapless Shoe
All Purpose Boot
Softie Shoe
Medical Surgical Shoe
Orthowedge
Original Medical Surgical Shoe
Duo Pro
WALKER LINER
MULTI PHASE PADS
PEG ASSIST
ACTIMOVE LINER
BODY ARMOR HEEL RELIEVER
SPENCO BOOT LINER
BODY ARMOR TOE GUARD
Pneumatic Night Splint
Body Armor Stirrup Walker Pneumatic
Air Traveler Walker
Body Armor PFA Walker Liner
Body Armor PFA Walker
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device