Vaporace®/Vaporgrip® Kabel, L 3, 0 m
FDA UDIEUDAMEDClass II (US FDA UDI)
by Joimax, Inc.
Identity
- Trade Name
- Vaporace®/Vaporgrip® Cable, L 3.0 m EUDAMEDVaporace®/Vaporgrip® Kabel, L 3,0 m FDA UDI
- Generic Name
- Electrosurgical system FDA UDI
- Device Name
- joimax® Neutral Electrode Connecting Cable EUDAMED
- Model / Reference
- VBFC8030 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250337118312 EUDAMEDFDA UDI
- Basic UDI-DI
- 42503371EPROVPG2 EUDAMED
- Direct Marketing DI
- 04250337118312 EUDAMED
- 510(k) Number
- K161378 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- L180302 ENDOSCOPIC ELECTROSURGERY HANDPIECES, REUSABLE EUDAMED
- GMDN Term
- Electrosurgical system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
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
No
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
No
Manufacturing Date
Yes
Category: Electrosurgical system
Vaporace®/Vaporgrip® Kabel, L 3, 0 m by Joimax, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Electrosurgical system.
- Bovie — BOVIE MEDICAL CORPORATION · Class II
- Macan — Macan Manufacturing · Class II
- Macan — Macan Manufacturing · Class II
- T4 Fine wire electrode — BONART CO., LTD. · Class II
- DIEGO ELITE — Gyrus Acmi, Inc. · Class II
- Macan — Macan Manufacturing · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- Bovie — BOVIE MEDICAL CORPORATION · Class II
Cleared under the same submission
K161378 also covers:
- Endovapor® — JOIMAX, INC.
- Legato® — JOIMAX, INC.
- Legato® — JOIMAX, INC.
- Legato® — JOIMAX, INC.
- Legato® — JOIMAX, INC.
- Legato® — JOIMAX, INC.
- Legato® — JOIMAX, INC.
- Vaporace® Hand Piece, bipolar — JOIMAX, INC.
- Vaporace® Probe bipolar, Area 150 mm – 3.5 mm — JOIMAX, INC.
- Vaporace® Probe bipolar, Area 270 mm – 3.5 mm — JOIMAX, INC.
- Vaporace® Probe bipolar, Area 320 mm – 3.5 mm — JOIMAX, INC.
- Vaporflex® — JOIMAX, INC.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Joimax, Inc.
Sources (2)
- FDA UDI 8a2f803d-03d2-4f22-bb40-9aefa5b80ff6 33 fields · synced Jun 19, 2026
- EUDAMED d67a3592-b18a-47a3-baf7-e54fc6eb7c8e 61 fields · synced Jun 19, 2026