Vaporace® Hand Piece, bipolar
FDA UDIEUDAMEDClass II (US FDA UDI)
by Joimax, Inc.
Identity
- Trade Name
- Vaporace® Handstück, bipolar EUDAMEDVaporace® Hand Piece, bipolar FDA UDI
- Generic Name
- Electrosurgical system FDA UDI
- Device Name
- Vaporace® Handstück, bipolar EUDAMED
- Model / Reference
- JVAH10010 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250337118978 EUDAMEDFDA UDI
- Basic UDI-DI
- 42503371EPROVRHMH EUDAMED
- Direct Marketing DI
- 04250337118978 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® Hand Piece, bipolar 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® 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.
- 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 e41ff773-f2c8-4db3-9905-21160b5c2d7e 33 fields · synced Jul 29, 2026
- EUDAMED 15274cb5-2357-4c8e-9ceb-b0b55a9ec317 61 fields · synced Jul 29, 2026