Identity
- Trade Name
- IMAK® RSI Elbow Support PM EUDAMEDIMAK RSI FDA UDI
- Generic Name
- Elbow joint orthosis component FDA UDI
- Device Name
- IMAK® RSI EUDAMEDElbow Support PM FDA UDI
- Model / Reference
- A10172 EUDAMEDFDA UDIUniversal EUDAMED
- Description
- Elbow Support PM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06498331017226 EUDAMED00649833101722 FDA UDI
- Basic UDI-DI
- 649833IMAKRESPMX6 EUDAMED
- FDA Product Code
- IOY FDA UDI
- EMDN Code
- M03050299 BANDAGES AND SPLINTS - OTHER EUDAMED
- GMDN Term
- Elbow joint orthosis component FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3475 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
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
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Category: Elbow joint orthosis component
Imak Rsi by Brownmed, Inc. — 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
- Brownmed, Inc.
Sources (2)
- FDA UDI 30c5fb97-ae49-4acb-b43a-ed5881c3c422 33 fields · synced Jul 11, 2026
- EUDAMED eb68bc1a-eb60-4bc8-b219-595987a5ce60 61 fields · synced Jul 11, 2026