# Advazorb Border

> Active: European Union. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/advazorb-border-cr4486>
- Manufacturer: [Brightwake Limited](https://devicerts.com/manufacturers/brightwake-limited) (United Kingdom)
- Device class: Class IIb (EU MDD); Class I (US FDA)
- FDA product code: NAC
- EMDN: M040499 DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER
- GMDN: Wound-nonadherent dressing, absorbent, non-antimicrobial (46854)

## Registrations and authorizations

- **EUDAMED** · CE/MDD · European Union · Basic UDI-DI B-05060031481846 · UDI-DI 05060031481846 · registered 2025-03-26 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI 05060031481846 · listed 2023-07-27 · status: Listed (GUDID: in commercial distribution)

## Recalls

No recall on record.

## Identity

- Generic name: Wound-nonadherent dressing, absorbent, non-antimicrobial [FDA GUDID (AccessGUDID)]
- Model / reference: CR4486 [EUDAMED, FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 05060031481846 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: B-05060031481846 [EUDAMED]
- FDA product code: NAC [FDA GUDID (AccessGUDID)]
- EMDN code: M040499 [EUDAMED]
- GMDN term: Wound-nonadherent dressing, absorbent, non-antimicrobial (46854) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class IIb [EUDAMED]; Class I [FDA GUDID (AccessGUDID)]
- Regulation number: 878.4018 [FDA GUDID (AccessGUDID)]
- EU registration type: Legacy device (under a directive) [EUDAMED]
- EU market of registration: France [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Dimensions & Sizes

- Size: Length — 8.5 Centimeter [FDA GUDID (AccessGUDID)]; Width — 7.5 Centimeter [FDA GUDID (AccessGUDID)]

## Properties

- Supplied sterile: Yes [EUDAMED, FDA GUDID (AccessGUDID)]
- Single use: Yes [FDA GUDID (AccessGUDID)]
- Premarket exempt: Yes [FDA GUDID (AccessGUDID)]
- Lot / batch number: Yes [FDA GUDID (AccessGUDID)]
- Expiration date: Yes [FDA GUDID (AccessGUDID)]
- Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Implantable: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reusable: No [EUDAMED]
- Contains latex: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reprocessed single-use device: No [EUDAMED]
- Incorporates a substance derived from human blood or plasma: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Administering medicine: No [EUDAMED]
- Measuring function: No [EUDAMED]
- Incorporates a medicinal substance: No [EUDAMED]
- Prescription use: No [FDA GUDID (AccessGUDID)]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Serial number: No [FDA GUDID (AccessGUDID)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Advazorb Border, Brightwake Limited. deviCERTS medical device catalogue. https://devicerts.com/devices/advazorb-border-cr4486 (data as of 2026-11-14).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/)
- Registry records last synced: 2026-10-25
- Statuses computed as of: 2026-11-14
- JSON: <https://devicerts.com/devices/advazorb-border-cr4486.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/advazorb-border-cr4486
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.