Identity
- Trade Name
- Swift® EUDAMEDSwift® Applicator Tip FDA UDI
- Generic Name
- Intraoperative gamma radiation detection system probe cover FDA UDI
- Device Name
- Swift® EUDAMEDSwift® applicator tip is provided as a single-use, non-sterile disposable tip, which is connected to the Swift® handpiece. FDA UDI
- Model / Reference
- Swift® Applicator Tip EUDAMEDSWF-AT01 EUDAMEDSWF-ATO1 FDA UDI
- Description
- Swift® applicator tip is provided as a single-use, non-sterile disposable tip, which is connected to the Swift® handpiece. FDA UDI
Identifiers
- Catalog Number
- SWF-ATO1 FDA UDI
- Primary DI / UDI-DI
- 05060652910039 EUDAMEDFDA UDI
- Basic UDI-DI
- 5060652910039UE EUDAMED
- 510(k) Number
- K181941 FDA UDI
- FDA Product Code
- NEY FDA UDI
- EMDN Code
- Z120608 MICROWAVE THERAPY EQUIPMENT EUDAMED
- GMDN Term
- Intraoperative gamma radiation detection system probe cover FDA UDI
Classification
- Device Class
- Class I 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Microwave ablation system probe, non-powered
Swift® by Emblation , Ltd. — Class I — 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 | 5060652910039UE | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 7221fcb8-cbd8-4a0e-a5dd-a54c9ac40de1 61 fields · synced Jun 1, 2026
- FDA UDI 8020ae16-57ce-4747-a538-a4e954e617e8 35 fields · synced May 30, 2026