Apis

FDA UDI

Class U (US FDA UDI)

by Sweetbio

Identity

Trade Name: APIS FDA UDI
Generic Name: Animal-derived wound matrix dressing FDA UDI
Device Name: Advanced Wound Care Product, double pouched, 25x25mm FDA UDI
Model / Reference: APIS-25x25-1 FDA UDI
Description: Advanced Wound Care Product, double pouched, 25x25mm FDA UDI

Identifiers

Catalog Number: APIS-25x25-1 FDA UDI
Primary DI / UDI-DI: 00861876000309 FDA UDI
FDA Product Code: FRO FDA UDI
GMDN Term: Animal-derived wound matrix dressing 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Radiation Sterilization FDA UDI

Dimensions & Sizes

Size: Length — 25 Millimeter FDA UDI
Width — 25 Millimeter FDA UDI
Height — 0.3 Millimeter FDA UDI

Category: Animal-derived wound matrix dressing

Apis by Sweetbio — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Animal-derived wound matrix dressing.

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Kerecis® GraftGuide® — KERECIS hf. · U
HealiAid Collagen Wound Dressing — MAXIGEN BIOTECH INC. · U
Solventum™ Promogran™ — Solventum US LLC · U
Simpurity — SAFE N SIMPLE LLC · U
ProgenaMatrix — Progenacare Global, LLC · U

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class U	Pending data

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Manufacturer

Manufacturer: Sweetbio

Sources (1)

FDA UDI 818e2e9c-8581-4328-92b9-882b686d2262 36 fields · synced May 29, 2026