← Back to catalogue
Aerin Console
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref CAT305-03Model CAT305-01510(k) K242630
Identity
- Trade Name
- Aerin Console EUDAMED
- Device Name
- Aerin Console EUDAMED
- Model / Reference
- CAT305-01 EUDAMEDCAT305-03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08886479300085 EUDAMED
- Basic UDI-DI
- 88864793CONSOLE00001HM EUDAMED
- Direct Marketing DI
- 08886479300085 EUDAMED
- EMDN Code
- L1899 ELECTROSURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
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
Category: Electrical-only medical device connection cable, reusable
Aerin Console by Aerin Medical Inc. — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Similar devices
Also classified as Electrical-only medical device connection cable, reusable.
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Guenter Bissinger Medizintechnik GmbH — Günter Bissinger Medizintechnik GmbH · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Symmetry Olsen — Olsen Medical · Class II
- Connection Cable — Shenzhen Keborui Electronics Co., Ltd · Class I
- TC-HEART LUNG DIN INTFC CA STOCKET — ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. · Class II
- MICTEC CONNECTION CABLE — SONTEC INSTRUMENTS, INC. · Class II
- ECG Cable — Edan Instruments,Inc. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
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 | K242630 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 88864793CONSOLE00001HM | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Aerin Medical, Inc.
- EUDAMED SRN
- US-MF-000048272
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 2f6dc6c2-0cb3-44b3-a0e4-1fc267f89530 85 fields · synced Jun 18, 2026
- FDA 510(k) K242630 1 fields · synced May 18, 2026