Identity
- Trade Name
- Phagenyx EUDAMEDFDA UDI
- Generic Name
- Pharyngeal electrical stimulation catheter FDA UDI
- Device Name
- Phagenyx Catheter EUDAMEDPhagenyx dysphagia treatment device FDA UDI
- Model / Reference
- PNX-1000 EUDAMEDFDA UDI
- Description
- Phagenyx dysphagia treatment device FDA UDI
Identifiers
- Catalog Number
- PNX-1000 FDA UDI
- Primary DI / UDI-DI
- 05060453480007 EUDAMEDFDA UDI
- Basic UDI-DI
- 506045348C019T EUDAMED
- 510(k) Number
- DEN220025 FDA UDI
- FDA Product Code
- QQG FDA UDI
- EMDN Code
- G02020101 NASOGASTRIC TUBES EUDAMED
- GMDN Term
- Pharyngeal electrical stimulation catheter 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
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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Phagenyx by Phagenesis Ltd — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 506045348C019T | 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 80dcf353-f436-4cf9-9213-1345937a0cfc 61 fields · synced Jun 18, 2026
- FDA UDI 668fb13c-15ef-407c-a521-1480f4bb49e5 37 fields · synced May 30, 2026