Identity
- Trade Name
- MEDLINE reusable hot and cold gel pack EUDAMED
- Device Name
- Reusable cold/hot gel compress EUDAMED
- Model / Reference
- 752801B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00064317280128 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
Category: Device sterilization/disinfection container, reusable
MEDLINE reusable hot and cold gel pack by Danyang Rapid Aid Hot and Cold Therapy Products Co., Ltd — Class I — MDR — listed in EUDAMED
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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 | 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 43b71ade-0ca6-4d5c-a0b8-1f8521a3c366 61 fields · synced Jul 12, 2026