Vaporace® Probe bipolar, Area 320 mm – 3.5 mm
FDA UDIEUDAMEDClass II (US FDA UDI)
by Joimax, Inc.
Identity
- Trade Name
- Vaporace® Probe bipolar, Area 320 mm – 3.5 mm EUDAMEDFDA UDI
- Generic Name
- Electrosurgical system FDA UDI
- Device Name
- Vaporflex® Probe 320 EUDAMED
- Model / Reference
- JVAPA32035 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250337118633 EUDAMEDFDA UDI
- Basic UDI-DI
- 42503371EPROPROLZ EUDAMED
- Direct Marketing DI
- 04250337118633 EUDAMED
- 510(k) Number
- K161378 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- K020199 MONO- AND BIPOLAR DEVICES, SINGLE USE - OTHER 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
- Germany 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
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
Yes
Manufacturing Date
Yes
Category: Electrosurgical system
Vaporace® Probe bipolar, Area 320 mm – 3.5 mm 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®/Vaporgrip® Kabel, L 3, 0 m — 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 2a15f1c3-b892-418c-82d1-0178d9639204 33 fields · synced Jul 17, 2026
- EUDAMED 235c942d-2c3b-460c-b669-b7a2eacbd5e3 61 fields · synced Jul 17, 2026