Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006026111

FEI Number

3006026111

Entity Name

DARCO (Europe) GmbH

City/State/Country

RAISTING Bavaria, DE

Establishment Address

GEWERBEGEBEIT 18, RAISTING Bavaria D-82399, DE

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

DARCO INTERNATIONAL, INC. (Owner Number: 9001626)

Owner / Operator Contact Address

810 MEMORIAL BLVD., --, Huntington, WV 25701, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IPX	Orthosis, Rib Fracture, Soft	Physical Medicine	Class 1	890.3490	2006-07-17
ITS	Joint, Hip, External Brace	Physical Medicine	Class 1	890.3475	2025-03-18
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2006-07-17
KNP	Orthosis, Corrective Shoe	Physical Medicine	Class 1	890.3475	2006-09-27
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2006-07-17
FZF	Splint, Extremity, Inflatable, External	General, Plastic Surgery	Class 1	878.3900	2007-03-19

Official Correspondent

MARK COOPER

US Agent Details

Mark Cooper Business: Darco International Inc. Email: mcooper@darcointernational.com Phone: (304) 5224883

Related Public Records

Same Entity

DARCO INTERNATIONAL, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1122845	DARCO INTERNATIONAL, INC.	HUNTINGTON, WV, US

Similar Registrations

Registration Number	Establishment Name	Location
3006227741	DYNAMIC TECHNO MEDICALS PRIVATE LIMITED	Coimbatore Tamil Nadu, IN
3030446844	PLATINUM FOCUS GROUP LTD.	London London, City of, GB
3017297225	BSN Medical GmbH	Hamburg, DE
3005273623	Heuer International (A division of GST Corporation Limited)	NOIDA Uttar Pradesh, IN
3013856565	HENGSHUI GANGSHENG MEDICAL INSTRUMENTS CO., LTD	Hengshui Hebei, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006026111. Last updated year: 2026. Please use registration number 3006026111 when referencing this establishment in official correspondence.