FDA.reportPublic FDA data

Redermax Antibacterial Wound Matrix

Primary DI
06977727072235
Brand
Redermax Antibacterial Wound Matrix
Company
Beijing Kreate Medical Co., Ltd.
Model
RDMX-0202
Device description
Redermax Antibacterial Wound Matrix is a sterile,single-use device intended for use in the management of wounds.
Published
2026-03-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251582000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251582000Redermax Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.2026-02-02FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06977727072235PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06977727072235069777270722356977727072235

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic wound matrix dressingA sterile bioabsorbable device designed to be applied to hard-to-heal wounds (e.g., diabetic and venous insufficiency ulcers) or burns that involve the dermis, and that provides a matrix of structural synthetic fibres to facilitate the infiltration of native skin elements (e.g., fibroblasts, leukocytes, blood vessels) for skin regeneration; it may in addition be intended to facilitate regeneration of hard tissues such as bone (e.g., in cases of osteomyelitis) and may provide wound exudate absorbency. It does not contain biological materials. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
843094168
Device count
1
Combination product
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06977727072617Redermo Wound MatrixRDMO-55D2026-04-30
06977727072624Redermo Wound MatrixRDMO-01012026-04-30
06977727072631Redermo Wound MatrixRDMO-02022026-04-30
06977727072648Redermo Wound MatrixRDMO-02032026-04-30
06977727072815SurCura Wound MatrixSCWM-55D2026-04-30
06977727072822SurCura Wound MatrixSCWM-01012026-04-30
06977727072839SurCura Wound MatrixSCWM-02022026-04-30
06977727072846SurCura Wound MatrixSCWM-02032026-04-30
06977727072211Redermax Antibacterial Wound MatrixRDMX-55D2026-03-23
06977727072228Redermax Antibacterial Wound MatrixRDMX-01012026-03-23
06977727072242Redermax Antibacterial Wound MatrixRDMX-02032026-03-23
06977727072419SurCura Antibacterial Wound MatrixSCAB-55D2026-03-23
06977727072426SurCura Antibacterial Wound MatrixSCAB-01012026-03-23
06977727072433SurCura Antibacterial Wound MatrixSCAB-02022026-03-23
06977727072440SurCura Antibacterial Wound MatrixSCAB-02032026-03-23

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Primary DI, Brand, Company table
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00852009002536Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
10197344169450MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-17
09551012610479ELECTROCYN somaV3BIO SDN. BHD.FRO2026-07-16
10197344176007MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
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