Amferia Wound Dressing

Primary DI
07350173540012
Brand
Amferia Wound Dressing
Company
Amferia AB
Model
80010
Catalog number
80010
Device description
Amferia Wound Dressing is intended to cover and protect dry to low exuding wounds and to maintain an appropriate moisture balance within the wound.
Published
2026-10-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
SHASolid Wound Dressing With Permanently Bound Antimicrobial Agent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SHASolid Wound Dressing With Permanently Bound Antimicrobial AgentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN250006000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN250006000Amferia Wound DressingAmferia AB2026-02-06SHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17350173540019PackageGS15In Commercial Distribution
07350173540012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1735017354001917350173540019
07350173540012073501735400127350173540012

GMDN Terms#

Term, Definition table
TermDefinition
Wound hydrogel dressing, antimicrobialA wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations, and that includes an antimicrobial agent, intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0
Width0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+46762981238qa@amferia.com

Regulatory Flags#

DUNS number
353319103
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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