Identity
- Trade Name
- MEDLINE reusable hot and cold gel pack EUDAMED
- Device Name
- Reusable cold/hot gel compress EUDAMED
- Model / Reference
- 752901T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00064317290110 EUDAMED
- Basic UDI-DI
- 64317reusableTY EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
MEDLINE reusable hot and cold gel pack by Danyang Rapid Aid Hot and Cold Therapy Products Co., Ltd — Class I — MDR — listed in EUDAMED
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 | 64317reusableTY | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000007052
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED ef80bc09-2928-4ab3-923c-f3c737f80cf4 61 fields · synced Oct 6, 2026