Identity
- Trade Name
- Peregrine System Infusion Catheter EUDAMED
- Device Name
- Peregrine System Infusion Catheter (4-7mm) EUDAMED
- Model / Reference
- FG32103 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00862468000301 EUDAMED
- Basic UDI-DI
- B-00862468000301 EUDAMED
- EMDN Code
- C0104020205 PHARMACEUTICAL INFUSION AND ADMINISTRATION INTRAVASCULAR CATHETERS AND MICROCATHETERS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Peregrine System Infusion Catheter by Ablative Solutions, Inc. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00862468000301 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Ablative Solutions Inc.
- EUDAMED SRN
- US-MF-000002880
- Authorised Representative
- ICON (LR) Limited IE-AR-000006507
Sources (1)
- EUDAMED 49187878-ef7c-44c0-8e9f-1235e4685c93 61 fields · synced May 20, 2026