Identity
- Trade Name
- Fully Automatic IHC Stainer EUDAMED
- Device Name
- Fully Automatic IHC Stainer EUDAMED
- Model / Reference
- AS300 EUDAMEDAS300 PLUS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06927210914443 EUDAMED
- Basic UDI-DI
- 697550352AS300SERMT EUDAMED
- Direct Marketing DI
- 06927210914443 EUDAMED
- EMDN Code
- W0202059002 AUTOMATED SLIDE STAINERS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
Yes
EUDAMED
Fully Automatic IHC Stainer by Shenzhen Dartmon Biotechnology Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697550352AS300SERMT | Class A | Active |
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Manufacturer
- Manufacturer
- Shenzhen Dartmon Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000019183
- Authorised Representative
- R Sight B.V. NL-AR-000010445
Sources (1)
- EUDAMED b21f2326-ef7a-4416-adf1-83842a481cd8 61 fields · synced Oct 8, 2026