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HypaSoothe Emergency Burn Gel
EUDAMEDClass IIa (EU MDR)
Ref 'D8164
by Pharmaplast
Identity
- Trade Name
- HypaSoothe Emergency Burn Gel EUDAMED
- Device Name
- Burn gel EUDAMED
- Model / Reference
- 'D8164 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05037331032047 EUDAMED
- Basic UDI-DI
- 62220238CavEmergencyNK EUDAMED
- EMDN Code
- M04040501 HYDROGEL DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class IIa 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
HypaSoothe Emergency Burn Gel by Pharmaplast — Class IIa — 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 | 62220238CavEmergencyNK | Class IIa | Active |
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Manufacturer
- Manufacturer
- Pharmaplast
- EUDAMED SRN
- EG-MF-000004501
- Authorised Representative
- E C REP LIMITED IE-AR-000003995
Sources (1)
- EUDAMED 5bb8c26f-405f-407a-9774-64bf91ffd0ec 61 fields · synced Jul 28, 2026