Identity
- Device Name
- NanoFx PleuriStik Guide Wires EUDAMED
- Model / Reference
- FURS-4101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00817337000364 EUDAMED
- Basic UDI-DI
- B-00817337000364 EUDAMED
- EMDN Code
- K030202 ARTHROSCOPY GUIDE WIRES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
NanoFx PleuriStik Guide Wires by Anika Therapeutics, Inc. — Class IIa — 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-00817337000364 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Anika Therapeutics, Inc.
- EUDAMED SRN
- US-MF-000041541
- Authorised Representative
- ANIKA THERAPEUTICS S.R.L. IT-AR-000028142
Sources (1)
- EUDAMED 07d2cdad-d151-450b-94e7-a204d5e2d683 61 fields · synced Jun 11, 2026