Identity
- Trade Name
- Disposable electrosurgical pads EUDAMEDDisposable Grounding Pad Series FDA UDI
- Generic Name
- Electrosurgical return electrode, single-use, sterile FDA UDI
- Device Name
- Disposable electrosurgical pads EUDAMED
- Model / Reference
- SY-M4 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06924274920045 EUDAMED06924274955351 FDA UDI
- Basic UDI-DI
- B-06924274920045 EUDAMED
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- K02010201 ELECTROSURGERY SINGLE PATIENT PADS (NEUTRAL ELECTRODES), SINGLE-USE EUDAMED
- GMDN Term
- Electrosurgical return electrode, single-use, sterile 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
Disposable electrosurgical pads by Zhejiang Shuyou Surgical Instrument Co., Ltd — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06924274920045 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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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 (2)
- EUDAMED fafc4a2a-310a-44d3-80ca-6d3a185ad4c8 61 fields · synced Jul 23, 2026
- FDA UDI e826d7f3-0cce-4505-bf03-cb263e3ce447 32 fields · synced May 30, 2026