FDA.reportPublic FDA data

Sensifine

Primary DI
06972949026103
Brand
Sensifine
Company
Hangzhou R&L Medical Device Co., Ltd
Model
HD
Device description
Hydrocolloid Bandage (Mixed Sizes). Each package contains a total of 11 patches: 9 circular patches (15mm) and 2 rectangular patches (20mm x 70mm).
Published
2025-12-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NADDressing, Wound, Occlusive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16972949026100PackageGS1500In Commercial Distribution
06972949026103PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697294902610016972949026100
06972949026103069729490261036972949026103

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobialA wound covering, typically made of a hydrocolloid, hydrofibre, chitosan or alginate (salts and acids extracted from seaweed), intended to produce a water-absorbent gel upon contact with wound exudate; it does not contain an antimicrobial agent. The device assists in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) for minimal wound maceration, allowing wound debridement, and creating a moist wound-healing environment. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, paste, or powder. After application, this device cannot be reused.

Regulatory Flags#

DUNS number
415588794
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06972949026097SensifineHD01012025-12-12
16972949026094SensifineHD01012025-12-12
16972949026100SensifineHD2025-12-12
06972949026110SensifineJ-15cm×12cm2025-12-08
06972949026127SensifineSGX0152025-12-08
16972949026117SensifineJ-15cm×12cm2025-12-08
16972949026124SensifineSGX0152025-12-08
86972949026031R&L MedicalJ-12cm×3cm2025-04-22
86972949026048R&L MedicalJ-12cm×3cm×2pcs2025-04-22
86972949026055R&L MedicalJ-12cm×6cm2025-04-22
86972949026062R&L MedicalJ-12cm×6cm×2pcs2025-04-22
86972949026079R&L MedicalJ-15cm×12cm2025-04-22
86972949026086R&L MedicalJ-15cm×12cm×2pcs2025-04-22
06972949026035R&L MedicalJ-12cm×3cm2025-04-22
06972949026042R&L MedicalJ-12cm×3cm×2pcs2025-04-22
06972949026059R&L MedicalJ-12cm×6cm2025-04-22
06972949026066R&L MedicalJ-12cm×6cm×2pcs2025-04-22
06972949026073R&L MedicalJ-15cm×12cm2025-04-22
06972949026080R&L MedicalJ-15cm×12cm×2pcs2025-04-22

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Primary DI, Brand, Company table
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