ONEPlatform™
FDA UDIEUDAMEDClass II (US FDA UDI)
by Medtec LLC
Identity
- Trade Name
- ONEPlatform™ FDA UDI
- Generic Name
- Radiological whole-body positioner FDA UDI
- Device Name
- 182.8cm FDA UDI
- Model / Reference
- BPL003 EUDAMEDFDA UDIStereotactic Body Radiation Therapy (SBRT) EUDAMED
- Description
- 182.8cm FDA UDI
Identifiers
- Catalog Number
- BPL003 FDA UDI
- Primary DI / UDI-DI
- 00841439102299 EUDAMEDFDA UDI
- Basic UDI-DI
- 8414391OC0017R01BH EUDAMED
- 510(k) Number
- K111340 FDA UDI
- FDA Product Code
- IYE FDA UDILNH FDA UDI
- EMDN Code
- Z12011299 PATIENT POSITIONING INSTRUMENTS – OTHER EUDAMED
- GMDN Term
- Radiological whole-body positioner FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI892.1000 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Radiological whole-body positioner
ONEPlatform™ by Medtec LLC — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K111340 also covers:
- Body Pro-Lok™ Bridge — Medtec LLC
- Body Pro-Lok™ Bridge — Medtec LLC
- Body Pro-Lok™ Bridge — Medtec LLC
- Body Pro-Lok™ Platform — Medtec LLC
- Body Pro-Lok™ System — Medtec LLC
- Clam-Lok™ Cushion — Medtec LLC
- Forehead Brace — Medtec LLC
- Lok-Bar™ — Medtec LLC
- Lok-Bar™ — Medtec LLC
- Lok-Bar™ — Medtec LLC
- ONEBridge™ — Medtec LLC
- ONEBridge™ — Medtec LLC
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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
- Medtec LLC
Sources (2)
- FDA UDI 20cb35e3-069e-4b4b-9eb1-2d262e9cb9c1 36 fields · synced Jul 17, 2026
- EUDAMED a28bbb02-1d21-4630-b9ea-deb99acf5add 61 fields · synced Jul 17, 2026