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IMAK® Compression
EUDAMEDFDA UDIClass I (EU MDR)
Ref A20173Model X- Small Ref 51021 Model Medium in bag Ref 51020 Model Small in bag Ref 51023 Model X-Large in bag
Identity
- Trade Name
- IMAK® Compression EUDAMEDX EUDAMEDNice Stretch FDA UDIIMAK Compression FDA UDI
- Generic Name
- Ankle/foot orthosis FDA UDICompression/pressure glove FDA UDI
- Device Name
- IMAK® Compression Arthritis Glove EUDAMEDNICE STRETCH® X EUDAMEDNice Stretch® X FDA UDIArthritis Glove FDA UDI
- Model / Reference
- X- Small EUDAMEDA20173 EUDAMEDFDA UDI51023 EUDAMEDFDA UDI51021 EUDAMEDFDA UDI51020 EUDAMEDFDA UDIMedium in bag EUDAMEDSmall in bag EUDAMEDX-Large in bag EUDAMED
- Description
- Nice Stretch® X FDA UDIArthritis Glove FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06498332017362 EUDAMED00821615102152 EUDAMED00821615102084 EUDAMED00821615102398 EUDAMED00082161510239 FDA UDI00082161510215 FDA UDI00649833201736 FDA UDI00082161510208 FDA UDI
- Basic UDI-DI
- 649833IMAKCARTGLVVL EUDAMED081261NSXMDB7U EUDAMED081261NSXVA EUDAMED081261NSXXLBAB EUDAMED
- FDA Product Code
- FYH FDA UDIILH FDA UDI
- EMDN Code
- M0304010101 ELASTIC COMPRESSION BANDAGES, NON-ADHESIVE, LOW EXTENSIBILITY (<70%) EUDAMEDM03050299 BANDAGES AND SPLINTS - OTHER EUDAMED
- GMDN Term
- Ankle/foot orthosis FDA UDICompression/pressure glove FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.3910 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 | 649833IMAKCARTGLVVL | 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 (8)
- EUDAMED d724d7a1-73d4-4af0-9926-4cf4b7a7d57b 61 fields · synced Jul 16, 2026
- FDA UDI 58690d0e-282a-4048-99e8-e8d2c4e89333 33 fields · synced May 29, 2026
- FDA UDI 0eb20ecc-6a30-4806-be6d-d82cb91b9023 33 fields · synced May 29, 2026
- FDA UDI 6972c1e1-1092-4d5c-93c8-e37299debcf0 33 fields · synced May 30, 2026
- FDA UDI bee68f01-5bed-4819-ace5-29c67aea0291 33 fields · synced May 30, 2026
- EUDAMED 99ecbff0-6a3e-4f6f-bdb2-ee10543d41df 61 fields · synced Jul 11, 2026
- EUDAMED 4e0453a6-0cae-4eee-8166-dd3946f98cd0 61 fields · synced Jul 14, 2026
- EUDAMED df32ba30-be2f-42fe-b4ba-9117f742ceb8 61 fields · synced Jul 16, 2026