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Monopolar Endoscopic Electrosurgical Instruments
EUDAMEDClass IIb (EU MDR)
Ref HD11081Model HD4-B10-Q0301Ref many
Identity
- Trade Name
- Monopolar Endoscopic Electrosurgical Instruments EUDAMEDAtraumatic Intestinal Forceps EUDAMED
- Device Name
- Monopolar Endoscopic Electrosurgical Instruments EUDAMED
- Model / Reference
- HD4-B10-Q0301 EUDAMEDHD11081 EUDAMEDmany EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06957270311081 EUDAMED
- Basic UDI-DI
- B-06957270311081 EUDAMED69572703GZ505QT EUDAMED
- EMDN Code
- K0201010602 LAPAROSCOPIC AND THORACOSCOPIC ELECTROSURGERY FORCEPS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMEDSpain 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
Monopolar Endoscopic Electrosurgical Instruments by Hunan Handlike Minimally Invasive Surgery Co., Ltd. — Class IIb — MDR, MDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06957270311081 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-06957270311081 | 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 (2)
- EUDAMED efc4cdbc-be4d-4742-adb7-189aede75d34 61 fields · synced Oct 6, 2026
- EUDAMED cb53d598-5598-4448-8403-0798ab6fda06 61 fields · synced May 17, 2026