Identity
- Trade Name
- Phagenyx EUDAMEDFDA UDI
- Generic Name
- Pharyngeal electrical stimulation control unit FDA UDI
- Device Name
- Phagenyx Base Station EUDAMEDPhagenyx Dysphagia Treatment Device FDA UDI
- Model / Reference
- EPSB3 EUDAMEDFDA UDI
- Description
- Phagenyx Dysphagia Treatment Device FDA UDI
Identifiers
- Catalog Number
- EPSB3 FDA UDI
- Primary DI / UDI-DI
- 05060453480045 EUDAMEDFDA UDI
- Basic UDI-DI
- 506045348B039S EUDAMED
- Direct Marketing DI
- 05060453480045 EUDAMED
- 510(k) Number
- DEN220025 FDA UDI
- FDA Product Code
- QQG FDA UDI
- EMDN Code
- Z12101106 NEUROLOGICAL STIMULATORS EUDAMED
- GMDN Term
- Pharyngeal electrical stimulation control unit FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.5950 FDA UDI
- Market of Registration
- Germany 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
No
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: Point aesthesiometer
Phagenyx by Phagenesis Ltd — Class IIa — 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 | 506045348B039S | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Phagenesis Ltd
- EUDAMED SRN
- GB-MF-000015848
- Authorised Representative
- Veranex Germany GmbH DE-AR-000005578
Sources (2)
- EUDAMED 3b7132f0-8a47-4a69-9e3d-5310c2da53fb 61 fields · synced Jul 17, 2026
- FDA UDI a1960e31-f381-4ec8-9df8-a4197e4da57f 37 fields · synced May 30, 2026