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Auto Slide Maker and Stainer
EUDAMEDClass A (EU MDR)
Ref XQ-0111-01Model SPAT X1
Identity
- Trade Name
- Auto Slide Maker and Stainer EUDAMED
- Device Name
- Auto Slide Maker and Stainer EUDAMED
- Model / Reference
- SPAT X1 EUDAMEDXQ-0111-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941377306415 EUDAMED
- Basic UDI-DI
- 697049309W02020000002A4 EUDAMED
- Direct Marketing DI
- 06941377306415 EUDAMED
- EMDN Code
- W0202059002 AUTOMATED SLIDE STAINERS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany 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
No
EUDAMED
Category: Microscope slide stainer IVD
Auto Slide Maker and Stainer by Shenzhen Dymind Biotechnology Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697049309W02020000002A4 | Class A | Active |
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Manufacturer
- Manufacturer
- Shenzhen Dymind Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000024842
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (1)
- EUDAMED 50339c30-bf43-4c0d-98c4-72cccc0b9bc9 61 fields · synced Jun 18, 2026