Identity
- Trade Name
- Adjust. UAS right EUDAMEDFDA UDI
- Generic Name
- Indexed-immobilization patient positioning system FDA UDI
- Device Name
- Armsupport EUDAMEDHeight adjustable arm support with flexible high armcup fit for OmniBoard, MultiBoard, BreastBoard SX, right FDA UDI
- Model / Reference
- 125320R EUDAMEDDSCP-AASR FDA UDI
- Description
- Height adjustable arm support with flexible high armcup fit for OmniBoard, MultiBoard, BreastBoard SX, right FDA UDI
Identifiers
- Catalog Number
- 125320R FDA UDI
- Primary DI / UDI-DI
- 08720168161581 EUDAMEDFDA UDI
- Basic UDI-DI
- 872016816125300J3 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
Adjust. UAS right by Macromedics B.v. — Class II — 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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Macromedics B.v.
Sources (2)
- FDA UDI b4993a85-001a-44a4-a74f-f9400518073e 34 fields · synced Aug 1, 2026
- EUDAMED b07f4ef3-27d7-4480-a21c-8294ad698c7b 61 fields · synced Aug 1, 2026