Identity
- Trade Name
- Vaporflex® Irrigation Shaft 275 EUDAMEDVaporflex® FDA UDI
- Generic Name
- Electrosurgical system FDA UDI
- Device Name
- Vaporflex® Shaft 320 EUDAMEDVaporflex® Irrigation Shaft 275 FDA UDI
- Model / Reference
- JVHS27527S EUDAMEDFDA UDI
- Description
- Vaporflex® Irrigation Shaft 275 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250337104056 EUDAMEDFDA UDI
- Basic UDI-DI
- 42503371EPROVFSM3 EUDAMED
- Direct Marketing DI
- 04250337104056 EUDAMED
- 510(k) Number
- K161378 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- Z12010999 ELECTROSURGERY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Electrosurgical 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: Electrosurgical system
Vaporflex® by Joimax, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Joimax, Inc.
Sources (2)
- FDA UDI 1f6093e1-eaa8-464e-a124-db8573fc7192 35 fields · synced Jun 19, 2026
- EUDAMED 75dbf312-3c1c-4454-8e9d-0c702f7a221a 61 fields · synced Jun 19, 2026