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Monopolar Endoscopic Electrosurgical Instruments
EUDAMEDClass IIb (EU MDR)
Ref HD10053Model HD4-B32-Q0104
Identity
- Trade Name
- Monopolar Endoscopic Electrosurgical Instruments EUDAMED
- Device Name
- Monopolar Endoscopic Electrosurgical Instruments EUDAMED
- Model / Reference
- HD4-B32-Q0104 EUDAMEDHD10053 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06957270310053 EUDAMED
- Basic UDI-DI
- B-06957270310053 EUDAMED
- EMDN Code
- K0201010602 LAPAROSCOPIC AND THORACOSCOPIC ELECTROSURGERY FORCEPS, 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
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 Endoscopic Electrosurgical Instruments by Hunan Handlike Minimally Invasive Surgery Co., Ltd. — Class IIb — MDD — listed in EUDAMED
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-06957270310053 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Hunan Handlike Minimally Invasive Surgery Co., Ltd.
- EUDAMED SRN
- CN-MF-000031727
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (1)
- EUDAMED cdf19af9-3d42-44f8-9fd4-f207befcdae6 61 fields · synced Jun 19, 2026