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Legato® Probe bipolar, Ball Tip
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref JBPP27020
by Joimax GmbH
Identity
- Trade Name
- Legato® Probe bipolar, Ball Tip EUDAMEDLegato® Probe bipolar EUDAMEDLegato® FDA UDI
- Generic Name
- Electrosurgical system FDA UDI
- Device Name
- Legato® Probe bipolar, Ball Tip EUDAMEDFDA UDIVaporflex® Probe 320 EUDAMED
- Model / Reference
- JBPP27020 EUDAMEDFDA UDI
- Description
- Legato® Probe bipolar, Ball Tip FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250337103790 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04250337103790 EUDAMED42503371EPROPROLZ EUDAMED
- Direct Marketing DI
- 04250337103790 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
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 bipolar, Ball Tip by Joimax GmbH — Class IIb — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04250337103790 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-04250337103790 | 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 (3)
- EUDAMED f9ab07fd-6284-471b-b542-193bbc9c13a0 61 fields · synced Jun 19, 2026
- FDA UDI 88cb6076-300a-47b3-b575-7791eb810fa2 35 fields · synced May 30, 2026
- EUDAMED abaf9b35-d837-436b-94a4-126332ebfa0b 61 fields · synced Jun 19, 2026