Identity
- Trade Name
- ACCU-THERM EUDAMED
- Device Name
- Ice Bags EUDAMED
- Model / Reference
- NON4420E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 20888277415123 EUDAMED
- Basic UDI-DI
- 0888277DC235NSKA EUDAMED
- Unit of Use DI
- 00888277415129 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 — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Hot/cold therapy pack, reusable.
- Future Generation Medical — Global International L. L. C. · Class I
- Hot Cold Pack - Universal customized Cartoon pack Jurassic & Gabby's Dollhouse — Wuhan Pakcare Bio‐technology Co.,Ltd. · Class I
- HOT/COLD THERAPY SLIPPER — Wuhan Pakcare Bio‐technology Co.,Ltd. · Class I
- PRONTO MED — Eurosirel Spa · Class IIa
- HOT/COLD THERAPEUTIC PACK FOR KNEE — Wuhan Pakcare Bio‐technology Co.,Ltd. · Class I
- hot cold pack — Anhui Kamt Ice Pack Co.,Ltd. · Class I
- HotCold Pack reusable — Bevaplast B.V. · Class I
- reusable cold hot gel pack for Ankle — Wuhan Pakcare Bio‐technology Co.,Ltd. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medline Industries, LP
- EUDAMED SRN
- US-MF-000009717
- Authorised Representative
- Medline International France FR-AR-000001814
Sources (1)
- EUDAMED 146f0c49-b705-46a1-855c-7456d57af667 61 fields · synced Jun 18, 2026