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Accu-Therm
EUDAMEDClass I (EU MDR)
Ref NON4460ERef NON4440ERef NON4430ERef NON4480ERef NON4410E
Identity
- Trade Name
- ACCU-THERM EUDAMED
- Device Name
- Ice Bags EUDAMED
- Model / Reference
- NON4460E EUDAMEDNON4440E EUDAMEDNON4430E EUDAMEDNON4480E EUDAMEDNON4410E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 20888277415147 EUDAMED20080196415141 EUDAMED20888277415130 EUDAMED20080196415158 EUDAMED20888277415116 EUDAMED
- Basic UDI-DI
- 0888277DC235NSKA EUDAMED0080196DC235NSZ5 EUDAMED
- Unit of Use DI
- 00888277415143 EUDAMED00080196415147 EUDAMED00888277415136 EUDAMED00080196415154 EUDAMED00888277415112 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
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- 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 |
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Manufacturer
- Manufacturer
- Medline Industries, LP
- EUDAMED SRN
- US-MF-000009717
- Authorised Representative
- Medline International France FR-AR-000001814
Sources (5)
- EUDAMED 36d8cb91-8c48-44e5-96be-0489f315d160 61 fields · synced Aug 2, 2026
- EUDAMED fc3d8098-47ce-44df-85b0-7d50a5c2838c 61 fields · synced May 17, 2026
- EUDAMED 8dd95720-b707-4c43-8ca2-5a59c8fe8edd 61 fields · synced May 17, 2026
- EUDAMED 921a9000-3ddf-4a40-991d-3b4ce36a6c00 61 fields · synced May 18, 2026
- EUDAMED cdfb7cee-fe25-4107-ba2c-a1d3d581f630 61 fields · synced May 18, 2026