Identity
- Trade Name
- DermaShine Balance EUDAMED
- Device Name
- Digital Infusion System EUDAMED
- Model / Reference
- Panace-DS-30 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800089800186 EUDAMED
- Basic UDI-DI
- B-08800089800186 EUDAMED
- EMDN Code
- Z12030302 SYRINGE PUMPS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Spain 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
DermaShine Balance by Huons Meditech Co., Ltd. — Class IIb — 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-08800089800186 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Huons Meditech Co., Ltd.
- EUDAMED SRN
- KR-MF-000016623
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (1)
- EUDAMED e1fac002-fd89-4074-9652-ad8df3d9f815 61 fields · synced Jul 10, 2026