Identity
- Trade Name
- RhinAer Stylus EUDAMED
- Device Name
- RhinAer Stylus EUDAMED
- Model / Reference
- CAT1395 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08886479300245 EUDAMED
- Basic UDI-DI
- 88864793RHINAER00002DD EUDAMED
- EMDN Code
- K02030109 RADIOFREQUENCY SURGERY HANDPIECES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
RhinAer Stylus by Aerin Medical Inc. — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K260522 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K161994 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 88864793RHINAER00002DD | Class IIb | Active |
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Manufacturer
- Manufacturer
- Aerin Medical, Inc.
- EUDAMED SRN
- US-MF-000048272
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED c6ce9938-c2be-49a5-adb8-a5c661bad5fb 85 fields · synced Jun 18, 2026
- FDA 510(k) K260522 1 fields · synced Jun 16, 2026