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IMAK® Compression
EUDAMEDFDA UDIClass I (EU MDR)
Ref 51055 Model Small - BlackModel Medium - Black
Identity
- Trade Name
- IMAK® Compression EUDAMEDSHIN SLEEVE™ EUDAMEDIMAK Compression FDA UDI
- Generic Name
- Calf/shin orthosis FDA UDI
- Device Name
- IMAK® Compression SHIN SLEEVE™ EUDAMEDIMAK® Compression SHIN SLEEVE™ EUDAMEDSHIN SLEEVE™ FDA UDI
- Model / Reference
- Small - Black EUDAMED51055 EUDAMEDFDA UDIMedium - Black EUDAMED
- Description
- SHIN SLEEVE™ FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821615105504 EUDAMED00082161510550 FDA UDI
- Basic UDI-DI
- 082161IMAKCSSXJ EUDAMED082161IMAKCSSMD2P4 EUDAMED
- FDA Product Code
- IQI FDA UDI
- EMDN Code
- M0304010101 ELASTIC COMPRESSION BANDAGES, NON-ADHESIVE, LOW EXTENSIBILITY (<70%) EUDAMED
- GMDN Term
- Calf/shin orthosis 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 | 082161IMAKCSSXJ | 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 (3)
- EUDAMED 71ea29dc-d0da-4232-9e8d-a2cbdf06be4d 61 fields · synced Jul 20, 2026
- FDA UDI 5bee694f-6900-4a9c-9c3c-0004de93e48f 33 fields · synced May 30, 2026
- EUDAMED 0401a770-dc49-43c8-bb51-ac48580c0c10 61 fields · synced Jul 20, 2026