Identity
- Trade Name
- Blue Dot Hot/Cold Pack (Each) EUDAMED
- Device Name
- Hot and cold pack EUDAMED
- Model / Reference
- 30REUHC1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05039139100362 EUDAMED
- Basic UDI-DI
- 5039139TF019QF EUDAMED
- EMDN Code
- M9099 GENERAL AND SPECIALIST MEDICAL DEVICES – OTHER (SUTURE PATCHES SEE H900102) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Blue Dot Hot/Cold Pack (Each) by Crest Medical Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 5039139TF019QF | Class I | Active |
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Manufacturer
- Manufacturer
- Crest Medical Limited
- EUDAMED SRN
- GB-MF-000025649
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED c1cbc260-9fb0-4d13-a927-84fc1ddb4c9e 61 fields · synced Jun 18, 2026