Identity
- Trade Name
- Iberis EUDAMED
- Device Name
- Renal Denervation Systems EUDAMED
- Model / Reference
- RD*ATGA008 EUDAMEDRD*ATCB160TC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06959582000240 EUDAMED06959582000233 EUDAMED
- Basic UDI-DI
- B-06959582000240 EUDAMEDB-06959582000233 EUDAMED
- EMDN Code
- Z12010999 ELECTROSURGERY INSTRUMENTS - OTHER EUDAMEDK02030101 RADIOFREQUENCY SURGERY ELECTRODES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMEDEUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMEDEUDAMED
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Iberis by Shanghai AngioCare Medical Technology Co., Ltd. — 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-06959582000240 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shanghai AngioCare Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000017311
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 447d4dc7-aced-4f97-80d5-240d8f4fab50 61 fields · synced Oct 6, 2026
- EUDAMED a2fb2bc0-76ee-4ef7-8b9d-60f59237c246 61 fields · synced May 18, 2026