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Auto Stainer
EUDAMEDClass A (EU MDR)
Ref 1315001010Model DL-DYE-ACID-16Ref 1315001009Model DL-DYE-GR-16
Identity
- Trade Name
- Auto Stainer EUDAMED
- Device Name
- Auto Stainer EUDAMED
- Model / Reference
- DL-DYE-ACID-16 EUDAMED1315001010 EUDAMEDDL-DYE-GR-16 EUDAMED1315001009 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971025210313 EUDAMED06971025210290 EUDAMED
- Basic UDI-DI
- 69710252103130820005CR EUDAMED69710252102900820003FP EUDAMED
- Direct Marketing DI
- 06971025210313 EUDAMED06971025210290 EUDAMED
- EMDN Code
- W0202059002 AUTOMATED SLIDE STAINERS EUDAMED
Classification
- Device Class
- Class A 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
Auto Stainer by Zhuhai DL Biotech 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 | 69710252103130820005CR | Class A | Active |
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Manufacturer
- Manufacturer
- Zhuhai DL Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000036485
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED af5a7c54-72d3-4708-a9b2-7ef05bce2f9c 61 fields · synced Jul 10, 2026
- EUDAMED ef779894-2294-4305-9482-45221f8ad4f5 61 fields · synced May 18, 2026