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Legato® Probe monopolar, Ball Tip
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref JMPP27025*
by Joimax GmbH
Identity
- Trade Name
- Legato® Probe monopolar, Ball Tip EUDAMEDLegato® FDA UDI
- Generic Name
- Radio-frequency ablation system FDA UDI
- Device Name
- Legato® Probe monopolar, Ball Tip EUDAMEDLegato® Probe monopolar, Ball Tip, straight FDA UDI
- Model / Reference
- JMPP27025* EUDAMEDFDA UDI
- Description
- Legato® Probe monopolar, Ball Tip, straight FDA UDI
Identifiers
- Catalog Number
- JMPP27025* FDA UDI
- Primary DI / UDI-DI
- 04250337115243 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04250337115243 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
- Radio-frequency ablation 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
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Legato® Probe monopolar, Ball Tip by Joimax GmbH — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04250337115243 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Joimax GmbH
- EUDAMED SRN
- DE-MF-000009201
Sources (2)
- EUDAMED 86325bc4-8c68-4c1a-847a-451c3792eda6 61 fields · synced Jun 18, 2026
- FDA UDI 567635c1-78bc-473d-9dda-fecdc3b972ea 36 fields · synced May 30, 2026