Aquasite®
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Aquasite Hydrogel Wound Dressing Amorphous Hydrogel 1 fl oz EUDAMEDAquasite® FDA UDI
- Generic Name
- Wound hydrogel dressing, non-antimicrobial FDA UDI
- Device Name
- Amorphous Hydrogel dressing. 1 oz. novel bellows tube. FDA UDI
- Model / Reference
- 81110 EUDAMEDFDA UDIAquasite Hydrogel Wound Dressings EUDAMED
- Description
- Amorphous Hydrogel dressing. 1 oz. novel bellows tube. FDA UDI
Identifiers
- Catalog Number
- DUP81110 FDA UDI
- Primary DI / UDI-DI
- 00809958080016 EUDAMEDFDA UDI
- Basic UDI-DI
- 0809958MDRTD0038L EUDAMED
- Direct Marketing DI
- 00809958080016 EUDAMED
- FDA Product Code
- NAE FDA UDI
- EMDN Code
- M04040501 HYDROGEL DRESSINGS, NON-COMBINED EUDAMED
- GMDN Term
- Wound hydrogel dressing, non-antimicrobial FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4022 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Wound hydrogel dressing, non-antimicrobial
Aquasite® by Derma Sciences Canada, Inc — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Wound hydrogel dressing, non-antimicrobial.
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Derma Sciences Canada, Inc
Sources (2)
- FDA UDI 0308772e-7a89-4af9-a5db-f038674b183a 37 fields · synced Jul 14, 2026
- EUDAMED 476812c8-a5ce-476b-96c3-b9861f99da35 61 fields · synced Jul 14, 2026