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Monopolar Endoscopic Electrosurgical Instruments
EUDAMEDClass IIb (EU MDR)
Ref HD10312Model HD4-B32-Q0301Ref HD10329Model HD4-B32-Q0302Ref HD11111Model HD4-B10-Q0304Ref HD10367Model HD4-B32-Q0502Ref HD11005Model HD4-B10-Q0101Ref HD10435Model HD4-B22-Q0202Ref HD10015Model HD4-B32-Q0102Ref HD11012Model HD4-B10-Q0102Ref HD10497Model HD4-B22-Q0501Ref HD10008Model HD4-B32-Q0101Ref HD310336Model HD4-B32-Q0303Ref HD04076Model HD4-B20-Q0205Ref HD10176Model HD4-B20-Q0202Ref HD11104Model HD4-B10-Q0303Ref HD10428Model HD4-B22-Q0201Ref HD10039Model HD4-B32-Q0103
Identity
- Trade Name
- Monopolar Endoscopic Electrosurgical Instruments EUDAMED
- Device Name
- Monopolar Endoscopic Electrosurgical Instruments EUDAMED
- Model / Reference
- HD4-B32-Q0301 EUDAMEDHD10312 EUDAMEDHD4-B32-Q0302 EUDAMEDHD10329 EUDAMEDHD4-B10-Q0304 EUDAMEDHD11111 EUDAMEDHD4-B32-Q0502 EUDAMEDHD10367 EUDAMEDHD4-B10-Q0101 EUDAMEDHD11005 EUDAMEDHD4-B22-Q0202 EUDAMEDHD10435 EUDAMEDHD4-B32-Q0102 EUDAMEDHD10015 EUDAMEDHD4-B10-Q0102 EUDAMEDHD11012 EUDAMEDHD4-B22-Q0501 EUDAMEDHD10497 EUDAMEDHD4-B32-Q0101 EUDAMEDHD10008 EUDAMEDHD4-B32-Q0303 EUDAMEDHD310336 EUDAMEDHD4-B20-Q0205 EUDAMEDHD04076 EUDAMEDHD4-B20-Q0202 EUDAMEDHD10176 EUDAMEDHD4-B10-Q0303 EUDAMEDHD11104 EUDAMEDHD4-B22-Q0201 EUDAMEDHD10428 EUDAMEDHD4-B32-Q0103 EUDAMEDHD10039 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06957270310312 EUDAMED06957270310329 EUDAMED06957270311111 EUDAMED06957270310367 EUDAMED06957270311005 EUDAMED06957270310435 EUDAMED06957270310015 EUDAMED06957270311012 EUDAMED06957270310497 EUDAMED06957270310008 EUDAMED06957270310336 EUDAMED06957270304076 EUDAMED06957270310176 EUDAMED06957270311104 EUDAMED06957270310428 EUDAMED06957270310039 EUDAMED
- Basic UDI-DI
- B-06957270310312 EUDAMEDB-06957270310329 EUDAMEDB-06957270311111 EUDAMEDB-06957270310367 EUDAMEDB-06957270311005 EUDAMEDB-06957270310435 EUDAMEDB-06957270310015 EUDAMEDB-06957270311012 EUDAMEDB-06957270310497 EUDAMEDB-06957270310008 EUDAMEDB-06957270310336 EUDAMEDB-06957270304076 EUDAMEDB-06957270310176 EUDAMEDB-06957270311104 EUDAMEDB-06957270310428 EUDAMEDB-06957270310039 EUDAMED
- EMDN Code
- K0201010602 LAPAROSCOPIC AND THORACOSCOPIC ELECTROSURGERY FORCEPS, SINGLE-USE EUDAMEDK0201010402 LAPAROSCOPIC AND THORACOSCOPIC ELECTROSURGERY SCISSORS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMEDAustria EUDAMEDSpain 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-06957270310312 | 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 (16)
- EUDAMED 5f4bcd68-e79e-429d-a3c3-aa6f32c6cb22 61 fields · synced Oct 6, 2026
- EUDAMED 6adcfdb7-a94c-42e3-8953-bde90968bdb0 61 fields · synced May 16, 2026
- EUDAMED d3ea255c-d696-4c6d-8d30-a0f1e480f943 61 fields · synced May 16, 2026
- EUDAMED 8bb6bc3d-2e28-4926-9044-e161f2e4b7a9 61 fields · synced May 16, 2026
- EUDAMED 48183bea-1de3-4468-a846-c939578b65cc 61 fields · synced May 16, 2026
- EUDAMED 5def089d-afa8-4e57-b2d8-5fc44c8e0c95 61 fields · synced May 17, 2026
- EUDAMED b9e148bc-3635-41b6-9fe8-e47826f572cd 61 fields · synced May 17, 2026
- EUDAMED d0750ed4-9146-4789-a615-afec947d75c9 61 fields · synced May 17, 2026
- EUDAMED 609066da-4107-4e1e-ad83-79c84e905b67 61 fields · synced May 17, 2026
- EUDAMED c84db893-e33c-4c8d-9ef0-c145d4a2a84b 61 fields · synced May 17, 2026
- EUDAMED b0f8a75a-bf87-4459-9124-5baf93913ba2 61 fields · synced May 18, 2026
- EUDAMED c6fafb82-24c1-4cdc-b0b7-4fe1de26da6c 61 fields · synced May 18, 2026
- EUDAMED bf804e8d-b021-4e9a-902f-c4c42c2c4f1b 61 fields · synced May 18, 2026
- EUDAMED 270ab7d1-5599-456d-a65b-fe1b019cdfc4 61 fields · synced May 18, 2026
- EUDAMED 3ead69dd-0457-44eb-9535-ac6ed354d8a9 61 fields · synced May 19, 2026
- EUDAMED 28462f31-ab0b-451b-b84f-03f609e4f61c 61 fields · synced May 19, 2026