Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680284

FEI Number

3002809016

Entity Name

3M EDUMEX, S.A DE C.V

City/State/Country

CD. JUAREZ Chihuahua, MX

Establishment Address

Avenida Ramon Rivera Lara 6620, Parque Industrial Ramon Rivera Lara, CD. JUAREZ Chihuahua 32605, MX

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Repack or Relabel Medical Device

Owner / Operator

3M COMPANY (Owner Number: 2110898)

Owner / Operator Contact Address

2510 Conway Avenue, Saint Paul, MN 55144, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SPLINT, HAND, AND COMPONENTS System, Thermal Regulating System, thermal regulating Dressing, wound, occlusive Drape, Surgical FIBER, MEDICAL, ABSORBENT Shield, eye, ophthalmic SUPPORT, ARM JOINT, ANKLE, EXTERNAL BRACE DRAPE, ADHESIVE, AEROSOL Orthosis, cervical PACK, HOT OR COLD, DISPOSABLE 3M Tape and bandage, adhesive Ring (wound protector), drape retention, internal 3M Tie-On Surgical Mask Mask, surgical Dressing, Wound, Hydrophilic BEDDING, DISPOSABLE, MEDICAL Drape, urological, disposable BINDER, ABDOMINAL JOINT, KNEE, EXTERNAL BRACE BANDAGE, ELASTIC Dressing, Compression PAD, EYE 3M Pack, hot or cold, reusable Drape, surgical, exempt

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2009-02-16
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2025-12-16
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2026-01-06
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2025-12-16
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2025-12-16
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2025-12-29
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2025-12-16
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2009-02-16
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	1992-12-15
KGT	Drape, Adhesive, Aerosol	General, Plastic Surgery	Class 1	878.4380	2025-12-26
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2009-02-16
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2025-12-29
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2003-08-21
KGW	Ring (Wound Protector), Drape Retention, Internal	General, Plastic Surgery	Class 2	878.4370	2025-12-29
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2007-12-11
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2025-12-19
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2026-01-05
EYY	Drape, Urological, Disposable	General, Plastic Surgery	Class 2	878.4370	2025-12-29
FSD	Binder, Abdominal	General Hospital	Class 1	880.5160	2009-02-16
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	1992-12-15
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2003-06-05
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2025-12-16
HMP	Pad, Eye	General, Plastic Surgery	Class 1	878.4440	2025-12-16
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	1997-02-20
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2025-12-26

Official Correspondent

DARLA ELGIN

US Agent Details

DARLA ELGIN Business: 3M Company Email: 3Mcompliance@mmm.com Phone: (651) 3988197

Related Public Records

Same Entity

3M COMPANY

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3005088750	3M POLAND MANUFACTURING SP. Z O.O	WROCLAW Dolnoslaskie, PL
3006580861	3M Japan Products Limited	Higashine-shi Yamagata, JP
1929938	3M COMPANY	Valley, NE, US
2122594	3M COMPANY	Hutchinson, MN, US
1717046	3M COMPANY	BROOKINGS, SD, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K171373	3M Company	3M Bair Hugger Model 675 Total Temperature Management System	2017-10-10
K083336	Smiths Medical Asd, Inc.	LEVEL 1 SNUGGLE WARM ADULT UNDERBODY CONVECTIVE WARMING BLANKET, MODEL SW-2013, LEVEL 1 SNUGGLE WARM LEFT LATERAL	2009-06-03
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31
K914369	Deroyal Industries, Inc.	QUALTEX MAGNETIC INSTRUMENT DRAPE	1991-12-02
K812809	Abco Dealers, Inc.	STERILE ADHERENT DRAPES	1981-11-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-2010	Cincinnati Sub-Zero Products Inc	2	WarmAir 135 Thermal Regulating System. Catalog Numbers: 86186-115 V, 06186-115 V (sold in the U.S.) and #86185-100 V ( not sold in the U.S.). Intended for warming patients before, during and after surgery, and other specialty procedures.
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0016-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

Similar Registrations

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3014125510	JIANGMEN HENG MEI GLOVES & DECORATION CO. LTD.	JIANGMEN Guangdong, CN
3023344913	AR ORTHOPEDICS, LLC	Newberry, FL, US
3041725026	Fill Mill	Lakewood, NJ, US
3012316249	COMPASS HEALTH BRANDS (CORPORATE OFFICE)	Middleburg Heights, OH, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9680284. Last updated year: 2026. Please use registration number 9680284 when referencing this establishment in official correspondence.