Identity
- Trade Name
- Vaporflex® Shaft 275 EUDAMEDVaporflex® FDA UDI
- Generic Name
- Radio-frequency ablation system FDA UDI
- Device Name
- Vaporflex® Shaft 320 EUDAMEDVaporflex® Shaft 275 FDA UDI
- Model / Reference
- JVHS28030 EUDAMEDFDA UDI
- Description
- Vaporflex® Shaft 275 FDA UDI
Identifiers
- Catalog Number
- JVHS28030 FDA UDI
- Primary DI / UDI-DI
- 04250337116783 EUDAMEDFDA UDI
- Basic UDI-DI
- 42503371EPROVFSM3 EUDAMED
- Direct Marketing DI
- 04250337116783 EUDAMED
- 510(k) Number
- K161378 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- Z12010999 ELECTROSURGERY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Radio-frequency ablation system FDA UDI
Classification
- Device Class
- Class IIa 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
EUDAMEDFDA UDI
Single Use
No
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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Radio-frequency ablation system
Vaporflex® by Joimax, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Radio-frequency ablation system.
- Dophi — Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. · Class II
- Cavi di connessione — ADVANCED MEDICAL SYSTEMS GROUP S.R.L. · Class I
- RF Ablation Electrode Kits — SURGNOVA HEALTHCARE TECHNOLOGIES (ZHEJIANG) CO., LTD. · Class IIb
- CP-16 TIP — Jeisys Medical Inc. · Class IIb
- 10THERMA Electrode — TENTECH Inc. · Class IIb
- Acessa ProVu PFG Table Clamp — ACESSA HEALTH INC. · Class II
- DIAMOND TIP — Jeisys Medical Inc. · Class IIb
- Dophi — Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. · 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.
- Vaporace®/Vaporgrip® Kabel, L 3, 0 m — JOIMAX, INC.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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 bd045a38-8fb7-4bf4-ad8a-9cbaaea8c58d 36 fields · synced Aug 1, 2026
- EUDAMED 92b4ee03-f97e-4d87-8042-7883de229b3c 61 fields · synced Aug 1, 2026