Identity
- Trade Name
- Electrosurgical Vessel Sealer/Divider EUDAMED
- Device Name
- Electrosurgical Vessel Sealer/Divider EUDAMED
- Model / Reference
- SL1320EA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974864547459 EUDAMED
- Basic UDI-DI
- 697486454SLDJB037S EUDAMED
- EMDN Code
- K0201010301 OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy 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
Category: Open-surgery electrosurgical electrode, monopolar, single-use
Electrosurgical Vessel Sealer/Divider by Nanjing ShouLiang-med Technology Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697486454SLDJB037S | Class IIb | Active |
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Manufacturer
- Manufacturer
- Nanjing ShouLiang-med Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000026898
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED e47dacbe-a79a-4d05-816e-24615bad6933 61 fields · synced Jun 19, 2026