Identity
- Trade Name
- RectalPro75 EUDAMEDQLRAD FDA UDI
- Generic Name
- Prostate immobilization balloon catheter FDA UDI
- Device Name
- RectalPro75 EUDAMEDFDA UDI
- Model / Reference
- 105.1001 EUDAMEDFDA UDI
- Description
- RectalPro75 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08719326258256 EUDAMEDFDA UDI
- Basic UDI-DI
- 87193262582105.1001RB EUDAMED
- 510(k) Number
- K180478 FDA UDI
- FDA Product Code
- PCT FDA UDI
- EMDN Code
- G0301010501 COLONIC BALLOON CATHETERS, LOW PRESSURE EUDAMED
- GMDN Term
- Prostate immobilization balloon catheter FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5720 FDA UDI
- Market of Registration
- Netherlands 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
Yes
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
Yes
FDA UDI
Category: Prostate immobilization balloon catheter
Qlrad by QLRAD international Ltd — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Prostate immobilization balloon catheter.
- IsoLoc — RADIADYNE, L.L.C. · Class II
- IsoLoc — RADIADYNE, L.L.C. · Class II
- QLRAD — QLRAD international Ltd · Class II
Cleared under the same submission
K180478 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- QLRAD international Ltd
Sources (2)
- FDA UDI 78e838cc-5418-4642-bf76-689016c8ea96 35 fields · synced Jul 9, 2026
- EUDAMED 04d0be96-e9fb-4cba-95b1-2a5cae30210c 61 fields · synced Jul 9, 2026