Identity
- Trade Name
- Baby Shark Hot/Cold Pack EUDAMED
- Device Name
- Hot or Cold packs EUDAMED
- Model / Reference
- X0055 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060738578719 EUDAMED
- Basic UDI-DI
- 506013188TF263U EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
Baby Shark Hot/Cold Pack by Reliance Medical Ltd — 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 | 506013188TF263U | Class I | Active |
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Manufacturer
- Manufacturer
- Reliance Medical Ltd
- EUDAMED SRN
- GB-MF-000004799
- Authorised Representative
- Reliance Medical (Ireland) IE-AR-000003675
Sources (1)
- EUDAMED d00783e6-2033-4382-a7be-e0191fe106e4 61 fields · synced Jul 26, 2026