Identity
- Trade Name
- S-49 Electrode EUDAMEDPOTENZA Tip FDA UDI
- Generic Name
- Electrosurgical system FDA UDI
- Device Name
- S-49 TIP EUDAMEDPOTENZA Tip (Sterile micro needle electrode S-49 Tip) FDA UDI
- Model / Reference
- S-49 TIP EUDAMEDS-49 EUDAMEDFDA UDI
- Description
- POTENZA Tip (Sterile micro needle electrode S-49 Tip) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800020107473 EUDAMED08800020111111 FDA UDI
- Basic UDI-DI
- B-08800020107473 EUDAMED
- 510(k) Number
- K192545 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- K020380 DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - ACCESSORIES EUDAMED
- GMDN Term
- Electrosurgical system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Netherlands 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
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Radio-frequency ablation system
S-49 Electrode by Jeisys Medical Inc. — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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-08800020107473 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Jeisys Medical Inc.
- EUDAMED SRN
- KR-MF-000008513
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 4dcba533-bd9b-41fc-99bc-cdef0ac39f2e 61 fields · synced Jul 12, 2026
- FDA UDI fa3edae3-b853-4896-92a6-c2dfd7bf85e6 34 fields · synced May 30, 2026