Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006755899

FEI Number

3006755899

Entity Name

BLUNDING S.A.

City/State/Country

MACUL SANTIAGO Region Metropolitana, CL

Establishment Address

LAS DALIAS 2465, MACUL SANTIAGO Region Metropolitana --, CL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Blunding S.A. (Owner Number: 9104922)

Owner / Operator Contact Address

Las Dalias, Macul Santiago, CL-NOTA 2465, CL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CC-611 CC-610 MI-330 , MI-333 MI-334 TA-614 TA-615 TA-418 TA-415 MI-123FR STABILIZER ANKLE BRACE MI-130NR ROM WALKER TA-414 TA-413 -14 HM ITEMS (-11 -130 -131 HM-132N SHOULDER STABILIZER BRACE HM-131 SHOULDER IMMOBILIZER BK07 BK08 HM-133 BK05 -126 -11P -131P) -125 E-910 E-729 E-732 BK06 HM-135 E-2010 E-2020 E-2030 E-2031 E-2032 E-718000 FORARM VENOUS IMMOBILIZER E-716000 HAND VENOUS IMMOBILIZER FOR BABY E-717000 VENOUS LINE PEDIATRIC FOREARM IMMOBILIZER MI-16 MI-14 PK-55 BK17 PK-54 PK-56 PK-51 PK-52 PK-53 ANKLE RIST SUPPORTER) , THIGH HM0123N AIRPRENE WRIST SUPPORT HM-117 WRIST SUPPORT MI-045NG AIRPRENE PATELLA KNEE STRAP WITH GEL MI-63N AIRPRENE KNEE POLYCENTIC STABILIZER MI-138 NIGHT TIME BUNION CORRECTOR BBE-01 BAMBOO WRIST SUPPORT HM-118 ELASTIC STABILIZING WRIST SUPPORT MI-42 ELASTIC KNEE SUPPORT BK14 KNEE SUPPORT BBE-06 BAMBOO ELBOW SUPPORT HM-0173N AIRPRENE THUMB SUPPORT HM-119 ELASTIC HAND WRIST SUPPORT MI-50N AIRPENE THIGH SUPPORT MI-320 ELASTIC THIGH SUPPORT MI-5400 OPEN PATELLA KNEE SUPPORT MI-121N AIRPRENE ANKLE SUPPORT BBE-04 BAMBOO ANKLE SUPPORT HM-16N AIRPRENE SHOULDER SUPPORT MI-128N AIRPRENE ANKLE STABILIZER SUPPORT MI-60N AIRPRENE KNEE SUPPORT MI-61N AIRPRENE OPEN PATELLA KNEE SUPPORT MI-62N AIRPRENE KNEE BRACE WITH 2 STAYS MI-47 POLYCENTRIC KNEE SUPPORT MI-45 ELASTIC PATELLAR TENDON SUPPORT MI-045N AIRPRENE PATELLA KNEE STRAP BBE-03 BAMBOO KNEE SUPPORT HM-120 ELASTIC WRIST SUPPORT MI-44 PATELLAR KNEE STABILIZER BBE-05 BAMBOO CALF SUPPORT VARIOUS(KNEE IMMOBILIZER KNEE AD-07 VARIOUS(WRIST SUPPORT OR OTHESIS OR HM-127 ADJUSTABLE THUMB SUPPORT BK12 FINGER IMMOBILIZER HM-116 WRIST IMMOBILIZER HM-170 WRIST BRACE BK11 THUMB IMMOBILIZER HM-172 WRIST BRACE WITH THUMB BK-10 WRIST IMMOBILIZER IZER) G-313 G-309 TA-311 TA-313 G308 MATERNITY SUPPORT G-310 CP-141 E-10900 HEADBOARD BED PROTECTOR E-104000 MATTRESS PROTECTOR E-1010 E-1020 E-1030 HM-14N HM-13 HM-12 HM-13N BK09 HM14 HM-15N HM-123 BK-22 PAVLIK HARNESS WITH BUCKLE BK19

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IPY	Orthosis, Lumbo-Sacral	Physical Medicine	Class 1	890.3490	2007-07-26
ITS	Joint, Hip, External Brace	Physical Medicine	Class 1	890.3475	2007-07-26
EZQ	Pouch, Colostomy	Gastroenterology, Urology	Class 1	876.5900	2007-07-26
EXN	Support, Hernia	Gastroenterology, Urology	Class 1	876.5970	2007-07-26
IQF	Orthosis, Cervical-Thoracic, Rigid	Physical Medicine	Class 1	890.3490	2014-08-27
KTD	Orthosis, Abdominal	Physical Medicine	Class 1	890.3490	2007-07-26
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2007-07-26
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2007-08-14
CBH	Device, Fixation, Tracheal Tube	Anesthesiology	Class 1	868.5770	2007-08-14
IQJ	Splint, Clavicle	Physical Medicine	Class 1	890.3490	2007-07-26
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2007-07-26
JCY	Catheter, Infusion	General, Plastic Surgery	Class 1	878.4200	2014-08-27
KNP	Orthosis, Corrective Shoe	Physical Medicine	Class 1	890.3475	2007-07-26
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2007-07-26
ILG	Stocking, Elastic	Physical Medicine	Class 1	890.3475	2007-07-26
IPR	Crutch	Physical Medicine	Class 1	890.3150	2010-05-08
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2007-07-26
KMO	Binder, Elastic	General Hospital	Class 1	880.5160	2007-07-26
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	2007-07-26
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2007-07-26
IOZ	Splint, Abduction, Congenital Hip Dislocation	Physical Medicine	Class 1	890.3665	2010-05-08

Official Correspondent

No official correspondent registered.

US Agent Details

Jay Mansour Business: Mansour Consulting LLC Email: jay@mansourconsulting.com Phone: (678) 9088180

Related Public Records

Same Entity

Blunding S.A.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006755899. Last updated year: 2026. Please use registration number 3006755899 when referencing this establishment in official correspondence.