Identity
- Trade Name
- Grounding Plate EUDAMEDFDA UDI
- Generic Name
- Electrosurgical return electrode, single-use FDA UDI
- Device Name
- RADIOSURGICAL UNITS EUDAMED
- Model / Reference
- 6510-00025-001 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800016902754 EUDAMEDFDA UDI
- Basic UDI-DI
- 8800016902693YC EUDAMED
- 510(k) Number
- K240248 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- X0599 HIGH INTENSITY ELECTROMAGNETIC RADIATION EMITTING EQUIPMENT WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED FOR USE ON THE HUMAN BODY, FOR SKIN RESURFACING, TATTOO OR HAIR REMOVAL OR OTHER SKIN TREATMENT – OTHER EUDAMED
- GMDN Term
- Electrosurgical return electrode, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Spain 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
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Grounding Plate by Classys — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8800016902693YC | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Classys
- EUDAMED SRN
- KR-MF-000010116
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED 30ff113f-945b-43e7-b3d6-b8d23b26b8fb 61 fields · synced Jul 19, 2026
- FDA UDI 17a78891-2990-4a33-b441-57b2c74b9852 33 fields · synced May 30, 2026