Identity
- Trade Name
- Ultrasonic Surgical System Generator EUDAMEDUltrasonic Surgical System Generators EUDAMED
- Device Name
- Ultrasonic Surgical System Generator EUDAMEDUltrasonic Surgical System Generators EUDAMED
- Model / Reference
- AH-611 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970950280026 EUDAMED
- Basic UDI-DI
- 6970950282b003AW EUDAMEDB-06970950280026 EUDAMED
- Direct Marketing DI
- 06970950280026 EUDAMED
- EMDN Code
- Z12010801 ULTRASONIC SCALPEL EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Ultrasonic Surgical System Generator by Affacare Medical (Beijing) Co., Ltd. — Class IIb — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 6970950282b003AW | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 6970950282b003AW | Class IIb | Active |
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Manufacturer
- Manufacturer
- Affacare Medical (Beijing) Co., Ltd.
- EUDAMED SRN
- CN-MF-000025388
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (2)
- EUDAMED 4389682a-1dbf-42e1-9c8c-e2aa187ba929 61 fields · synced Jul 20, 2026
- EUDAMED 88c22218-9117-4554-b7cf-6a2d56e5a193 61 fields · synced May 18, 2026