Identity
- Trade Name
- Hot/Cold Sleeve EUDAMED
- Device Name
- Polar Ice™ Hot/Cold Sleeve EUDAMED
- Model / Reference
- Small/Medium EUDAMED31615 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00082161316152 EUDAMED
- Basic UDI-DI
- 082161PISLVA9 EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Hot/cold therapy pack, reusable
Hot/Cold Sleeve by Brownmed, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Hot/cold therapy pack, reusable.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 082161PISLVA9 | Class I | Active |
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Manufacturer
- Manufacturer
- Brownmed, Inc.
- EUDAMED SRN
- US-MF-000008271
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED 3781d034-faa6-42ae-b27d-c3b44d8ffef8 61 fields · synced Jul 10, 2026