Identity
- Trade Name
- VENISTAR EUDAMEDFDA UDI
- Generic Name
- Peripheral vascular radio-frequency ablation catheter FDA UDI
- Device Name
- VENISTAR EUDAMED
- Model / Reference
- 3-VENI0030N EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809306767868 EUDAMEDFDA UDI
- Basic UDI-DI
- 880930676VENISTAR_E8G EUDAMEDB-08809306767868 EUDAMED
- 510(k) Number
- K222997 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- K0201010301 OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMED
- GMDN Term
- Peripheral vascular radio-frequency ablation catheter FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Bulgaria EUDAMEDFrance EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Open-surgery electrosurgical electrode, monopolar, single-use
Venistar by Starmed Co., Ltd — Class IIb — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 880930676VENISTAR_E8G | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 880930676VENISTAR_E8G | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- STARmed Co., Ltd.
- EUDAMED SRN
- KR-MF-000008605
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 410d5122-5ad4-4f00-befd-e7a1b78ea4ec 61 fields · synced Jul 26, 2026
- EUDAMED e4392d99-125e-4119-b8d8-766d48b5c14b 61 fields · synced May 17, 2026
- FDA UDI c2930c8e-d604-4007-a93e-ab60263e1097 33 fields · synced May 26, 2026