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
Catalogue
Adhesive Remover Ref MED L120450
Hartmann MedProtect barrier film Spray Ref 995102
Superfiller Ref F05008C
Superfiller Ref 22214
Superfiller Ref F05008
Askina Barrier Film Swab Ref 5037
Onyster® Polyurethane Film Nail Plaster Ref 080318
Hartmann MedProtect barrier cream Ref 995101
Ally Barrier Film Spray Ref 5036
Skin Cleanser Ref SF2351
Peristomal Paste Ref FM00160
Askina Barrier Cream Ref 5038
Superfiller Ref F05008F
Adhesive Remover Ref ER5012
Askina Barrier Film Spray Ref 5036
Adhesive Remover Ref ER0250
Skin Cleanser Ref SS2351
Hartmann MedProtect Barrier Film Swab Ref 995103
EUDAMED certificates
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
Related companies
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.
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.
Information
- Country
- Ireland
- Address
- Ballinalee Rd,, IDA Business Park,, Longford, Ireland
- Website
- medical.averydennison.com
- [email protected]
- Phone
- +353 43 33 49586
- PRRC contact
- Elaine Minagh
- EUDAMED SRN
- IE-MF-000001926