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Multifunctional Operational Dissectors（Electrosurgical pencils）
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref SY-IIA(N)-2
Identity
- Trade Name
- Multifunctional Operational Dissectors（Electrosurgical pencils） EUDAMEDPeng’s Multifunctional Operative Dissector(PMOD) FDA UDI
- Generic Name
- Electrosurgical handpiece, single-use FDA UDI
- Device Name
- Multifunctional Operational Dissectors（Electrosurgical pencils） EUDAMED
- Model / Reference
- SY-IIA(N)-2 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06924274910138 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06924274910138 EUDAMED
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- K0201010201 OPEN ELECTROSURGERY DISSECTORS, SINGLE-USE EUDAMED
- GMDN Term
- Electrosurgical handpiece, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Multifunctional Operational Dissectors（Electrosurgical pencils） by Zhejiang Shuyou Surgical Instrument Co., Ltd — Class IIb — FDA_510K, MDD — listed in…
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K260466 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-06924274910138 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Zhejiang Shuyou Surgical Instrument Co., Ltd
- EUDAMED SRN
- CN-MF-000025970
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (3)
- EUDAMED b658a1ad-8a50-41fc-bfde-4bea0f344e50 61 fields · synced Jun 19, 2026
- FDA UDI 429c2e3c-1195-45f8-a46f-4420b2b0cab4 32 fields · synced May 30, 2026
- FDA 510(k) K260466 1 fields · synced Jun 9, 2026