Identity
- Trade Name
- Bipolar Instruments EUDAMED
- Device Name
- Ultrasonic Surgical& Electrosurgical System EUDAMED
- Model / Reference
- AG52320SM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16972304755263 EUDAMED
- Basic UDI-DI
- 69723047500046V EUDAMED
- EMDN Code
- Z12010980 ELECTROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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
Bipolar Instruments by Surgnova Healthcare Technologies (zhejiang) Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69723047500046V | Class IIb | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000014087
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 08a5772d-077f-49b4-8b47-19084fb17bd7 61 fields · synced Jul 14, 2026