Identity
- Trade Name
- Skin fold Breast Wedge EUDAMEDQLRAD FDA UDI
- Generic Name
- Patient radiation shielding pad/drape, reusable FDA UDI
- Device Name
- Breast Wedge EUDAMEDInframammary Fold Breast Wedge Small FDA UDI
- Model / Reference
- 105.2000 EUDAMEDFDA UDI
- Description
- Inframammary Fold Breast Wedge Small FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08720892233004 EUDAMEDFDA UDI
- Basic UDI-DI
- 87193262582105.2000RG EUDAMED
- FDA Product Code
- KPY FDA UDI
- EMDN Code
- T030499 RADIOTHERAPY PROTECTION DEVICES - OTHER EUDAMED
- GMDN Term
- Patient radiation shielding pad/drape, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 892.6500 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: Patient radiation shielding pad/drape, reusable
Qlrad by QLRAD international Ltd — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- QLRAD international Ltd
Sources (2)
- FDA UDI 1f66b06c-90a6-45ee-a20e-9b8d41baddbf 34 fields · synced Jun 19, 2026
- EUDAMED df703917-bd01-4656-8186-75350479a1ca 61 fields · synced Jun 19, 2026