Identity
- Trade Name
- Smart Glove EUDAMEDIMAK RSI FDA UDI
- Generic Name
- Compression/pressure glove FDA UDI
- Device Name
- IMAK® RSI Smart Glove EUDAMEDSmart Glove FDA UDI
- Model / Reference
- A20125 EUDAMEDFDA UDISmall EUDAMED
- Description
- Smart Glove FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06498332012558 EUDAMED00649833201255 FDA UDI
- Basic UDI-DI
- 649833IMAKRSGGF EUDAMED
- FDA Product Code
- ILH FDA UDI
- EMDN Code
- M0304010101 ELASTIC COMPRESSION BANDAGES, NON-ADHESIVE, LOW EXTENSIBILITY (<70%) EUDAMED
- GMDN Term
- Compression/pressure glove 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: Compression/pressure glove
Imak Rsi by Brownmed, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Compression/pressure glove.
- Juzo Soft Seamless — JULIUS ZORN, INC. · Class I
- Juzo Custom Compression Garments — JULIUS ZORN, INC. · Class I
- Juzo Soft — JULIUS ZORN, INC. · Class I
- Juzo Soft Seamless — JULIUS ZORN, INC. · Class I
- Juzo Soft — JULIUS ZORN, INC. · Class I
- Juzo Custom Compression Garments — JULIUS ZORN, INC. · Class I
- Juzo Soft Seamless — JULIUS ZORN, INC. · Class I
- Juzo Dynamic — JULIUS ZORN, INC. · Class I
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 fb5de48f-3772-484c-a6a2-42f6fb22b297 33 fields · synced Jun 19, 2026
- EUDAMED 00917d28-6d84-404d-8c55-5582f5e9e337 61 fields · synced Jun 19, 2026