Identity
- Trade Name
- ACCU-THERM EUDAMED
- Device Name
- Ice Bags EUDAMED
- Model / Reference
- NON4410E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 20888277415116 EUDAMED
- Basic UDI-DI
- 0888277DC235NSKA EUDAMED
- Unit of Use DI
- 00888277415112 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
Accu-Therm by Medline Industries, LP — Class I — CE/MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 0888277DC235NSKA | Class I | Active |
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Manufacturer
- Manufacturer
- Medline Industries, LP
- EUDAMED SRN
- US-MF-000009717
- Authorised Representative
- Medline International France FR-AR-000001814
Sources (1)
- EUDAMED cdfb7cee-fe25-4107-ba2c-a1d3d581f630 61 fields · synced Oct 6, 2026