Identity
- Trade Name
- 2nd Derma Gold PTT EUDAMED
- Device Name
- Moisturizing dermal gel EUDAMED
- Model / Reference
- SSDERMA01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809663760526 EUDAMED
- Basic UDI-DI
- 880966376SSDERMANNGL EUDAMED
- Direct Marketing DI
- 08809663760526 EUDAMED
- EMDN Code
- M9002 PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Norway 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
2nd Derma Gold PTT by SIMFLE STICK 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 | 880966376SSDERMANNGL | Class I | Active |
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Manufacturer
- Manufacturer
- SIMFLE STICK Co., Ltd.
- EUDAMED SRN
- KR-MF-000037179
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (1)
- EUDAMED 78a5aee6-fafd-4f84-aec5-4ca87d7b1958 61 fields · synced Jun 18, 2026