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Swift®
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref SWF-GE01Model Swift® Microwave Generator
Identity
- Trade Name
- Swift® EUDAMEDSwift® Microwave Generator FDA UDI
- Generic Name
- Microwave hyperthermia system FDA UDI
- Device Name
- Swift® EUDAMEDThe Swift® microwave generator is intended to be used with the Swift® applicator for the coagulation of soft tissue. FDA UDI
- Model / Reference
- Swift® Microwave Generator EUDAMEDSWF-GE01 EUDAMEDFDA UDI
- Description
- The Swift® microwave generator is intended to be used with the Swift® applicator for the coagulation of soft tissue. FDA UDI
Identifiers
- Catalog Number
- SWF-GE01 FDA UDI
- Primary DI / UDI-DI
- 05060652910008 EUDAMEDFDA UDI
- Basic UDI-DI
- 5060652910008U3 EUDAMED
- 510(k) Number
- K181941 FDA UDI
- FDA Product Code
- NEY FDA UDI
- EMDN Code
- Z120608 MICROWAVE THERAPY EQUIPMENT EUDAMED
- GMDN Term
- Microwave hyperthermia system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Northern Ireland 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: Microwave ablation system probe, non-powered
Swift® by Emblation , Ltd. — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5060652910008U3 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Emblation Ltd
- EUDAMED SRN
- GB-MF-000021381
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 49563391-4b2f-4186-aec3-d9d40ce22227 61 fields · synced May 30, 2026
- FDA UDI 0c367dc6-e248-4e5e-b83f-a5647f98f917 35 fields · synced May 30, 2026