Identity
- Trade Name
- INSTANT ICE PACK EUDAMED
- Device Name
- INSTANT ICE PACK EUDAMED
- Model / Reference
- HEA113 S-L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976057823401 EUDAMED
- Basic UDI-DI
- 69760578229Z2 EUDAMED
- EMDN Code
- M0409 DRESSINGS FOR PHOTO- AND THERMOTHERAPY IN THE FORM OF GELS AND SOLUTIONS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Instant Ice Pack by Ningbo Unico Products Co., 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 | 69760578229Z2 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ningbo Unico Products Co., Ltd
- EUDAMED SRN
- CN-MF-000039604
- Authorised Representative
- Everbiz GmbH DE-AR-000008964
Sources (1)
- EUDAMED cdd3cbfe-33ff-4127-951b-a2fc738c452f 61 fields · synced Jun 19, 2026