Identity
- Device Name
- Acriflex Skin Cooling Gel EUDAMED
- Model / Reference
- 155376 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05011309899917 EUDAMED
- Basic UDI-DI
- B-05011309899917 EUDAMED
- EMDN Code
- M04040501 HYDROGEL DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Acriflex Skin Cooling Gel by Thornton & Ross Ltd — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05011309899917 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Thornton & Ross Ltd
- EUDAMED SRN
- GB-MF-000009462
- Authorised Representative
- HÄLSA Pharma GmbH DE-AR-000007406
Sources (1)
- EUDAMED ed5ec783-ccf1-4933-83fb-ae0a654f9774 61 fields · synced Jul 9, 2026