Identity
- Trade Name
- Pro-Tx Endorectal Balloon EUDAMED
- Device Name
- Pro-Tx Endorectal Balloon EUDAMED
- Model / Reference
- PROT-25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10850011472122 EUDAMED
- Basic UDI-DI
- 008500114724000238CKT EUDAMED
- Direct Marketing DI
- 00850011472125 EUDAMED
- EMDN Code
- Z11010485 RADIOTHERAPY TREATMENT PLANNING INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Pro-Tx Endorectal Balloon by Dxtx Medical Inc — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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 | K223249 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 008500114724000238CKT | Class I | Active |
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Manufacturer
- Manufacturer
- DxTx Medical, Inc.
- EUDAMED SRN
- US-MF-000026795
- Authorised Representative
- MedR-AR Services B.V. NL-AR-000000120
Sources (2)
- EUDAMED f6070884-a676-4544-ac8a-1488ea10a64d 61 fields · synced Jun 19, 2026
- FDA 510(k) K223249 1 fields · synced May 18, 2026