Identity
- Trade Name
- Skin marker EUDAMED
- Device Name
- Skin marker EUDAMED
- Model / Reference
- AK-400 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978589535890 EUDAMED
- Basic UDI-DI
- 69785895306978589535890QL EUDAMED
- EMDN Code
- V9004 SKIN MARKING DERMOGRAPHIC PENCILS AND PENS EUDAMED
Classification
- Device Class
- Class I 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
Skin marker by Ningbo Alps Medical Technology 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 | 69785895306978589535890QL | Class I | Active |
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Manufacturer
- Manufacturer
- Ningbo Alps Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000047878
- Authorised Representative
- Humiss Beratung GmbH DE-AR-000023447
Sources (1)
- EUDAMED ea8a21dd-be4a-4202-9714-23ddd2b1a150 61 fields · synced Jul 14, 2026