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Megadyne
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref MEGEN1Model Ethicon MEGADYNE Electrosurgical Generator(MEGEN1)
Identity
- Trade Name
- Megadyne EUDAMEDFDA UDI
- Generic Name
- Electrosurgical system generator FDA UDI
- Device Name
- Ethicon MEGADYNE Electrosurgical Generator EUDAMEDFDA UDI
- Model / Reference
- Ethicon MEGADYNE Electrosurgical Generator(MEGEN1) EUDAMEDMEGEN1 EUDAMEDFDA UDI
- Description
- Ethicon Megadyne Electrosurgical Generator FDA UDI
Identifiers
- Catalog Number
- MEGEN1 FDA UDI
- Primary DI / UDI-DI
- 10614559105597 EUDAMEDFDA UDI
- Basic UDI-DI
- 0614559a00001BH EUDAMED
- Direct Marketing DI
- 10614559105597 EUDAMED
- 510(k) Number
- K193145 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- Z12010902 ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE EUDAMED
- GMDN Term
- Electrosurgical system generator FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Belgium 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Foot-switch, electrical
Megadyne by Megadyne Medical Products, Inc. — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K213696 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 0614559a00001BH | Class IIb | Active |
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Manufacturer
- Manufacturer
- Megadyne Medical Products, Inc.
- EUDAMED SRN
- US-MF-000017046
- Authorised Representative
- Johnson & Johnson Medical GmbH DE-AR-000007712
Sources (3)
- EUDAMED ea370d69-a707-46fe-8c53-47825ebf4b40 61 fields · synced Jul 21, 2026
- FDA UDI e6810f06-0798-4e82-a7e8-d1973d4bfb46 36 fields · synced May 30, 2026
- FDA 510(k) K213696 1 fields · synced May 18, 2026