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Avery Dennison Medical, Ltd.

Ireland IE-MF-000001926 Last updated 25 Oct 2026 Part of Avery Dennison Medical

Devices
19
Registries
EUDAMEDFDA 510(k)
FDA recalls
0

Catalogue19

EUDAMED certificates1

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

EUDAMED certificates (1)

Notified body 2797 1 certificate

  • MDR 738647 Amended

    Quality management system EU MDR

    Issued
    10 Aug 2026
    Expires
    5 Jan 2029
    Reason
    Mnf data change

Notified bodies

  • Notified body 2797

What Avery Dennison Medical, Ltd. makes

Avery Dennison Medical produces surgical incise drapes infused with chlorhexidine gluconate (CHG) antimicrobial solution, designed to reduce surgical site infections during procedures.

The company’s products are regulated as Class II medical devices in the U.S. and are listed via FDA 510(k) clearance. The manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Avery Dennison Medical, Ltd. manufacture?

Avery Dennison Medical, Ltd. specializes in surgical incise drapes infused with chlorhexidine gluconate (CHG) antimicrobial solution. These products are designed to help reduce surgical site infections during medical procedures by providing an antimicrobial barrier.

Where is Avery Dennison Medical, Ltd. based?

The company is headquartered in the United States. While the exact location isn’t specified, its regulatory filings and operations are conducted from within the U.S., aligning with its manufacturing focus on FDA-regulated medical devices.

How are Avery Dennison Medical, Ltd.’s devices classified in the U.S.?

The company’s devices, such as surgical incise drapes with antimicrobial properties, are classified as Class II medical devices under U.S. regulations. This classification applies because the products pose moderate risk and require special controls to ensure safety and effectiveness, such as antimicrobial efficacy testing and labeling requirements.

Which regulatory registries or databases list Avery Dennison Medical, Ltd.’s devices?

Avery Dennison Medical, Ltd.’s devices are listed in the FDA 510(k) database, which tracks Class II medical devices that have undergone premarket notification clearance in the U.S. This registry confirms the devices meet FDA requirements for safety and performance before commercial distribution.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
Ireland
Address
Ballinalee Rd,, IDA Business Park,, Longford, Ireland
Phone
+353 43 33 49586 
PRRC contact
Elaine Minagh
EUDAMED SRN
IE-MF-000001926