FDA.reportPublic FDA data

SurCura Wound Matrix

Primary DI
06977727072877
Brand
SurCura Wound Matrix
Company
Beijing Kreate Medical Co., Ltd.
Model
SCWM-5050
Device description
SurCural Wound Matrix is a sterile,single-use device intended for use in the management of wounds.
Published
2026-10-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
QSZAbsorbable Synthetic Wound Dressing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QSZAbsorbable Synthetic Wound DressingUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K260020000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K260020000Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.2026-04-16QSZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06977727072877PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06977727072877069777270728776977727072877

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.

Regulatory Flags#

DUNS number
843094168
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06977727072259Redermax® Antibacterial Wound MatrixRDMX-14D2026-10-08
06977727072266Redermax® Antibacterial Wound MatrixRDMX-25252026-10-08
06977727072273Redermax® Antibacterial Wound MatrixRDMX-50502026-10-08
06977727072280Redermax® Antibacterial Wound MatrixRDMX-50752026-10-08
06977727072457SurCura Antibacterial Wound MatrixSCAB-14D2026-10-08
06977727072464SurCura Antibacterial Wound MatrixSCAB-25252026-10-08
06977727072471SurCura Antibacterial Wound MatrixSCAB-50502026-10-08
06977727072488SurCura Antibacterial Wound MatrixSCAB-50752026-10-08
06977727072655Redermo Wound MatrixRDMO-14D2026-10-08
06977727072662Redermo Wound MatrixRDMO-25252026-10-08
06977727072679Redermo Wound MatrixRDMO-50502026-10-08
06977727072686Redermo Wound MatrixRDMO-50752026-10-08
06977727072853SurCura Wound MatrixSCWM-14D2026-10-08
06977727072860SurCura Wound MatrixSCWM-25252026-10-08
06977727072884SurCura Wound MatrixSCWM-50752026-10-08
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06977727072655Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.QSZ2026-10-08
06977727072662Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.QSZ2026-10-08
06977727072679Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.QSZ2026-10-08
06977727072686Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.QSZ2026-10-08
06977727072853SurCura Wound MatrixBeijing Kreate Medical Co., Ltd.QSZ2026-10-08
06977727072860SurCura Wound MatrixBeijing Kreate Medical Co., Ltd.QSZ2026-10-08
06977727072884SurCura Wound MatrixBeijing Kreate Medical Co., Ltd.QSZ2026-10-08
09349155003865NovoSorb SynPathPOLYNOVO BIOMATERIALS PTY LIMITEDQSZ2026-06-25
09349155003988NovoSorb SynPathPOLYNOVO BIOMATERIALS PTY LIMITEDQSZ2026-06-25
09349155004169NovoSorb SynPathPOLYNOVO BIOMATERIALS PTY LIMITEDQSZ2026-06-25
09349155004404NovoSorb SynPathPOLYNOVO BIOMATERIALS PTY LIMITEDQSZ2026-06-25
06977727072617Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.QSZ2026-04-30
06977727072624Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.QSZ2026-04-30
06977727072631Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.QSZ2026-04-30
06977727072648Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.QSZ2026-04-30
06977727072815SurCura Wound MatrixBeijing Kreate Medical Co., Ltd.QSZ2026-04-30
06977727072822SurCura Wound MatrixBeijing Kreate Medical Co., Ltd.QSZ2026-04-30
06977727072839SurCura Wound MatrixBeijing Kreate Medical Co., Ltd.QSZ2026-04-30
06977727072846SurCura Wound MatrixBeijing Kreate Medical Co., Ltd.QSZ2026-04-30
00854258006389Restrata(R)Acera Surgical IncQSZ2026-04-15
00854258006396Restrata MeshedAcera Surgical IncQSZ2026-04-15
00850021883072SiOxD® ORSioxmed, LLCQSZ2026-03-17
00812005030537Mirragen Advanced Wound MatrixETS Wound Care LLCQSZ2026-03-03
00817337000616HyalomatrixAnika Therapeutics, Inc.QSZ2026-02-22
00850021883003SiOxD Wound MatrixSioxmed, LLCQSZ2025-11-10
00850021883041SiOxD Wound MatrixSioxmed, LLCQSZ2025-11-10
00850047730305Foundation DRS SoloBionova Medical Inc.QSZ2025-09-17
00850047730312Foundation DRS SoloBionova Medical Inc.QSZ2025-09-17
00850047730329Foundation DRS SoloBionova Medical Inc.QSZ2025-09-17
00850047730336Foundation DRS SoloBionova Medical Inc.QSZ2025-09-17