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MANUKAtex 10 x 12.5 cm

FDA UDI

Class U (US FDA UDI)

by Manukamed Limited Partnership

Identity

Trade Name
MANUKAtex 10 x 12.5 cm FDA UDI
Generic Name
Wound-nonadherent dressing, permeable, antimicrobial FDA UDI
Model / Reference
MM0010 FDA UDI

Identifiers

Primary DI / UDI-DI
05060188820468 FDA UDI
510(k) Number
K110042 FDA UDI
FDA Product Code
FRO FDA UDI
GMDN Term
Wound-nonadherent dressing, permeable, antimicrobial FDA UDI

Classification

Device Class
U FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Wound-nonadherent dressing, permeable, antimicrobial

MANUKAtex 10 x 12.5 cm by Manukamed Limited Partnership — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Wound-nonadherent dressing, permeable, antimicrobial.

Cleared under the same submission

K110042 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Manukamed Limited Partnership

Sources (1)

  • FDA UDI 64126cf5-0100-42f8-861c-16fa95bbe711 33 fields · synced Jun 7, 2026