Ablative Solutions Inc.

United States US-MF-000002880 Last updated 25 Oct 2026

Devices: 5
Registries: EUDAMEDGUDIDFDA 510(k)FDA
FDA recalls: 0

Catalogue5

Peregrine System™ Infusion Catheter FG32111 Ref FG32111

Class II FDA UDI
Peregrine System Infusion Catheter FG32101 Ref FG32101

Class II FDA UDI
Peregrine System™ Infusion Catheter FG32112 Ref FG32112

Class II FDA UDI
Peregrine System Infusion Catheter Ref FG32103

Class IIb EUDAMED Active
Peregrine System Infusion Catheter Ref FG32109

Class IIb EUDAMEDFDA 510(k) Active

EUDAMED certificates1

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

GMED SAS 0459 1 certificate

40421 Amended

Quality management system EU MDR

Issued
18 Aug 2026

Expires
3 Feb 2031

Reason
Other

Notified bodies

GMED SAS 0459

FDA establishments1

Registered with the FDA under this company group, matched by name.

Ablative Solutions, Inc. Wakefield, MA · US FEI 3010334444

About

[email protected] | Declaration of Compliance | Privacy Statement | Terms & Conditions

From the manufacturer's own website. Source

Information

Country: United States(from SRN)
Address: 301, Edgewater Place • Suite 100, Wakefield, United States
Website: www.ablativesolutions.com
Email: [email protected]
Phone: +1 650-688-9743
PRRC contact: Kristine Canavan
EUDAMED SRN: US-MF-000002880
DUNS number: 078293273