Identity
- Trade Name
- IMAK® Compression EUDAMEDIMAK Compression FDA UDI
- Generic Name
- Compression/pressure sock/stocking, reusable FDA UDI
- Device Name
- IMAK® Compression Arthritis Socks EUDAMEDArthritis Sock FDA UDI
- Model / Reference
- Small EUDAMEDA20190 EUDAMEDFDA UDI
- Description
- Arthritis Sock FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06498332019038 EUDAMED00649833201903 FDA UDI
- Basic UDI-DI
- 649833IMAKCASD6 EUDAMED
- FDA Product Code
- ITW FDA UDI
- EMDN Code
- M0304010101 ELASTIC COMPRESSION BANDAGES, NON-ADHESIVE, LOW EXTENSIBILITY (<70%) EUDAMED
- GMDN Term
- Compression/pressure sock/stocking, reusable 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
IMAK® Compression by Brownmed, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 649833IMAKCASD6 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Brownmed, Inc.
- EUDAMED SRN
- US-MF-000008271
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (2)
- EUDAMED 4bb90dd5-1a19-4a22-b00d-3a3af9cd6cf7 61 fields · synced Jul 21, 2026
- FDA UDI b35b0a89-1bf1-4279-aab8-65a26c531708 33 fields · synced May 30, 2026