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BPL Respiratory Belt
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref MTSBRT015Model Stereotactic Body Radiation Therapy (SBRT)
by Medtec LLC
Identity
- Trade Name
- BPL Respiratory Belt FDA UDI
- Generic Name
- Radiological whole-body positioner FDA UDI
- Device Name
- BPL Respiratory Belt FDA UDI
- Model / Reference
- MTSBRT015 EUDAMEDFDA UDIStereotactic Body Radiation Therapy (SBRT) EUDAMED
- Description
- BPL Respiratory Belt FDA UDI
Identifiers
- Catalog Number
- MTSBRT015 FDA UDI
- Primary DI / UDI-DI
- 00841439113554 EUDAMEDFDA UDI
- Basic UDI-DI
- 8414391OC0017R01BH EUDAMED
- 510(k) Number
- K153026 FDA UDI
- FDA Product Code
- LNH FDA UDIIYE 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
- 892.1000 FDA UDI892.5050 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
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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Radiological whole-body positioner
BPL Respiratory Belt 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
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
- Medtec LLC
Sources (2)
- FDA UDI 9b2a1080-a2d6-46b6-b0fb-7f89ee3cace1 36 fields · synced Jul 11, 2026
- EUDAMED a9341a91-d1e5-4506-90e3-6f03cbd59786 61 fields · synced Jul 11, 2026