Identity
- Trade Name
- Instant cold pack EUDAMEDRapid Relief Cold FDA UDI
- Generic Name
- Hot/cold therapy pack, single-use FDA UDI
- Device Name
- Instant Cold Pack EUDAMEDRapid Relief Instant Cold Pack (single use) FDA UDI
- Model / Reference
- 31259 EUDAMEDFDA UDI
- Description
- Rapid Relief Instant Cold Pack (single use) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00064317312591 EUDAMEDFDA UDI
- Basic UDI-DI
- 64317ravinstcoldF9 EUDAMED
- Direct Marketing DI
- 00064317312591 EUDAMED
- FDA Product Code
- IMD FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Hot/cold therapy pack, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 890.5710 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Device sterilization/disinfection container, reusable
Instant cold pack by Rapid Aid Vietnam Co., Ltd — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 64317ravinstcoldF9 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Rapid Aid Vietnam Co., Ltd
- EUDAMED SRN
- VN-MF-000033576
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED bcd599e5-2902-442b-bd5f-fe7ac886a99e 61 fields · synced Jun 18, 2026
- FDA UDI 68246358-b660-49d3-a450-505f885ad69a 33 fields · synced May 29, 2026