Identity
- Trade Name
- Legato® Hand Piece, monopolar EUDAMEDLegato® FDA UDI
- Generic Name
- Electrosurgical system FDA UDI
- Device Name
- Legato® Hand Piece, monopolar EUDAMEDFDA UDI
- Model / Reference
- JMPH352504 EUDAMEDFDA UDI
- Description
- Legato® Hand Piece, monopolar FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250337103783 EUDAMEDFDA UDI
- Basic UDI-DI
- 42503371EPROLHEL EUDAMED
- Direct Marketing DI
- 04250337103783 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
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
Legato® 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.
- 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.
- Vaporflex® — 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 3c1b3a33-262e-4521-ac63-5511bceb6d87 35 fields · synced Jul 9, 2026
- EUDAMED d5f23b92-2b57-451f-86fd-56808aa3a248 61 fields · synced Jul 9, 2026