Identity
- Trade Name
- Cooling gel sheet EUDAMED
- Model / Reference
- BI-1-05 EUDAMEDY-T3167 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06924441200017 EUDAMED
- Basic UDI-DI
- 692444120001CC EUDAMED
- EMDN Code
- M040199 PREPARED DRESSINGS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Croatia 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
Cooling gel sheet by Foshan Biours Biosciences 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 | 692444120001CC | Class I | Active |
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Manufacturer
- Manufacturer
- Foshan Biours Biosciences Co., Ltd.
- EUDAMED SRN
- CN-MF-000042947
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED e42ad485-bc08-4096-baae-041a5e6dc08a 61 fields · synced Jun 18, 2026