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IMAK® Compression
EUDAMEDFDA UDIClass I (EU MDR)
Ref A20157 Model LargeRef A20170 Model Small Ref A20172 Ref A20155Model SmallRef A20156 Model MediumRef A20152Ref A20185Ref A22130Model M/LRef 52520Model Universal Retail Box Ref A20325Ref A22131Model L/XLRef A20150Ref A20130
Identity
- Trade Name
- IMAK® Compression EUDAMEDIMAK Compression FDA UDI
- Generic Name
- Hip/knee orthosis FDA UDIWrist orthosis FDA UDICompression/pressure glove FDA UDIElbow joint orthosis component FDA UDI
- Device Name
- IMAK® Compression Arthritis Elbow Sleeve EUDAMEDIMAK® Compression Arthritis Glove EUDAMEDIMAK® Compression Arthritis Knee EUDAMEDIMAK® Compression Active Glove EUDAMEDIMAK® Compression Copper Knee EUDAMEDIMAK® Compression Eye Pillow Grey EUDAMEDIMAK® Compression Arthritis Gloves - 1 Pair - Black EUDAMEDIMAK® Compression Arthritis Wrist EUDAMEDArthritis Knee FDA UDIArthritis Wrist Sleeve FDA UDIActive Glove FDA UDIArthritis Glove - Black FDA UDIArthritis Elbow FDA UDI
- Model / Reference
- Large EUDAMEDA20157 EUDAMEDSmall EUDAMEDA20170 EUDAMEDA20172 EUDAMEDA20155 EUDAMEDFDA UDIMedium EUDAMEDA20156 EUDAMEDA20152 EUDAMEDFDA UDIA20130 EUDAMEDFDA UDIA20185 EUDAMEDFDA UDIA20325 EUDAMEDFDA UDIA20150 EUDAMEDFDA UDIM/L EUDAMEDA22130 EUDAMEDUniversal Retail Box EUDAMED52520 EUDAMEDL/XL EUDAMEDA22131 EUDAMED
- Description
- Arthritis Knee FDA UDIArthritis Wrist Sleeve FDA UDIActive Glove FDA UDIArthritis Glove - Black FDA UDIArthritis Elbow FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06498332015764 EUDAMED06498332017058 EUDAMED06498332017294 EUDAMED06498332015528 EUDAMED06498332015696 EUDAMED00649833203259 EUDAMEDFDA UDI06498332015214 EUDAMED06498332018598 EUDAMED00082161221302 EUDAMED00082161525202 EUDAMED00082161221319 EUDAMED06498332015078 EUDAMED06498332013098 EUDAMED00649833201521 FDA UDI00649833201309 FDA UDI00649833201859 FDA UDI00649833201552 FDA UDI00649833201507 FDA UDI
- Basic UDI-DI
- 649833IMAKCAESLG5S EUDAMED649833IMAKCARTGLVSMR5 EUDAMED649833IMAKCARTGLVLGQ4 EUDAMED649833IMAKCAESFY EUDAMED649833IMAKCAESMD5P EUDAMED649833IMAKCAKLGP5 EUDAMED649833IMAKCACTGLVQF EUDAMED649833IMAKCKMLHU EUDAMED649833IMAKEPGRYU6 EUDAMED649833IMAKCAGLGNH EUDAMED649833IMAKCKLXLSW EUDAMED649833IMAKCAKSMQ6 EUDAMED649833IMAKCAWDE EUDAMED
- FDA Product Code
- ISY FDA UDIILH FDA UDIIOY FDA UDI
- EMDN Code
- M0304010101 ELASTIC COMPRESSION BANDAGES, NON-ADHESIVE, LOW EXTENSIBILITY (<70%) EUDAMED
- GMDN Term
- Hip/knee orthosis FDA UDIWrist orthosis FDA UDICompression/pressure glove FDA UDIElbow joint orthosis component FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3420 FDA UDI890.3475 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 | 649833IMAKCAESLG5S | 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 (19)
- EUDAMED 4f5f8677-2c12-4535-93f8-c2ee21080e28 61 fields · synced Sep 17, 2026
- EUDAMED 482af176-97f0-45f3-ba33-1fba299647b6 61 fields · synced May 17, 2026
- EUDAMED d2c41ca3-9f8b-4f9f-9a7d-e41a904d8e71 61 fields · synced May 18, 2026
- EUDAMED c3580470-167b-4623-9fce-4f75fb57cdef 61 fields · synced May 18, 2026
- EUDAMED 419652c7-8212-4222-b6b3-f9a0d8254344 61 fields · synced May 18, 2026
- FDA UDI 708a7505-4197-4a2a-aad1-d853c67a1d69 33 fields · synced May 25, 2026
- FDA UDI e9add97c-b8de-48fe-a6c8-70f859f5b3c2 33 fields · synced May 29, 2026
- FDA UDI 92bf4f7e-fa92-4975-b3f6-fb83c8661cd0 33 fields · synced May 29, 2026
- FDA UDI 4e3ee0ad-4b72-4374-8471-83f06915ffb1 33 fields · synced May 30, 2026
- FDA UDI 675e8ed1-6230-4620-865e-33494cd5d52a 33 fields · synced May 30, 2026
- FDA UDI d2e1350a-7e90-45d0-9f79-ae19e351334b 33 fields · synced May 30, 2026
- EUDAMED a83e1846-ec8f-4a9e-88be-ec19930e33d3 61 fields · synced Jul 11, 2026
- EUDAMED c29d84fa-c51d-4477-9aef-a148713a8662 61 fields · synced Jul 13, 2026
- EUDAMED dd90cb0e-eeb4-4367-b067-00080cab2f99 61 fields · synced Jul 13, 2026
- EUDAMED 240df386-9d2b-43bb-a2d9-7efde0b7d303 61 fields · synced Jul 14, 2026
- EUDAMED e67b5db6-9cf9-435f-8f26-90269e3e822d 61 fields · synced Jul 16, 2026
- EUDAMED 26907bfc-5101-49fb-85f4-7c38f12c7cc0 61 fields · synced Jul 18, 2026
- EUDAMED 8938ae1e-60a0-4759-99ea-a3b1240db4c6 61 fields · synced Jul 30, 2026
- EUDAMED 9f60c8a6-c045-495f-886b-0cb31f368864 61 fields · synced Sep 17, 2026