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Monopolar Open-surgery Electrosurgical Handpiece (including electrode) For Sing…
EUDAMEDClass IIb (EU MDR)
Ref PS-01
Identity
- Trade Name
- Monopolar Open-surgery Electrosurgical Handpiece (including electrode) For Single-use EUDAMED
- Device Name
- Monopolar Open-surgery Electrosurgical Handpiece (including electrode) For Single-use EUDAMED
- Model / Reference
- PS-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973343319983 EUDAMED
- Basic UDI-DI
- B-06973343319983 EUDAMED
- EMDN Code
- K02030101 RADIOFREQUENCY SURGERY ELECTRODES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Monopolar Open-surgery Electrosurgical Handpiece (including electrode) For Sing… by Hunan Jingyi Medical Technology Co., Ltd. — Class IIb — MDD — listed in…
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-06973343319983 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Hunan Jingyi Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000028676
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (1)
- EUDAMED ddbf27b6-4111-43c2-90bb-486349612732 61 fields · synced Aug 3, 2026