Identity
- Trade Name
- FlexBoard™ BTM-SX EUDAMEDFDA UDI
- Generic Name
- Indexed-immobilization patient positioning system FDA UDI
- Device Name
- BreastBoard EUDAMEDBreast Treatment Module SX for FlexBoard FDA UDI
- Model / Reference
- 174630 EUDAMEDFB-BTMSX FDA UDI
- Description
- Breast Treatment Module SX for FlexBoard FDA UDI
Identifiers
- Catalog Number
- 174630 FDA UDI
- Primary DI / UDI-DI
- 08720168160744 EUDAMEDFDA UDI
- Basic UDI-DI
- 872016816122500HQ EUDAMED
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z12011280 PATIENT POSITIONING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Indexed-immobilization patient positioning system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Market of Registration
- Northern Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Indexed-immobilization patient positioning system
FlexBoard™ BTM-SX by Macromedics B.v. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Indexed-immobilization patient positioning system.
- QUANTUM™ CT Overlay — Qfix · Class II
- KLARITY MEDICAL — Klarity Medical Products, LLC · Class II
- KLARITY MEDICAL — Klarity Medical Products, LLC · Class II
- KLARITY MEDICAL — Klarity Medical Products, LLC · Class II
- IPPS™ Overlay — Medtec LLC · Class II
- KLARITY MEDICAL — Klarity Medical Products, LLC · Class II
- KLARITY MEDICAL — Klarity Medical Products, LLC · Class II
- Arm Support, Single Adjust, Elekta Compatible — Aktina Corp. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Macromedics B.v.
Sources (2)
- FDA UDI 01c5d1b7-b7e2-4dc0-b47b-09ee96c097ff 34 fields · synced Jun 19, 2026
- EUDAMED ac4a326f-e1d7-4e79-bed0-f56f2e8e2e4a 61 fields · synced Jun 19, 2026