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Auto microbial identification and antimicrobial susceptibility testing system
EUDAMEDClass A (EU MDR)
Ref 1403001011Model D2Mini
Identity
- Trade Name
- Auto microbial identification and antimicrobial susceptibility testing system EUDAMED
- Device Name
- Auto microbial identification and antimicrobial susceptibility testing system EUDAMED
- Model / Reference
- D2Mini EUDAMED1403001011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971025210528 EUDAMED
- Basic UDI-DI
- 69710252105281116001GN EUDAMED
- Direct Marketing DI
- 06971025210528 EUDAMED
- EMDN Code
- W02030199 ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - OTHER 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
No
EUDAMED
Auto microbial identification and antimicrobial susceptibility testing system by Zhuhai DL Biotech Co., Ltd. — Class A — IVDR — listed in EUDAMED
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 | 69710252105281116001GN | 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 (1)
- EUDAMED d12a7c31-3ee7-4b98-9bf3-ad5b9ec9ac12 61 fields · synced Jun 17, 2026