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Fully auto microbial identification and antimicrobial susceptibility testing sy…
EUDAMEDClass A (EU MDR)
Ref 1502040005Model DL-96A
Identity
- Trade Name
- Fully auto microbial identification and antimicrobial susceptibility testing system EUDAMED
- Device Name
- Fully auto microbial identification and antimicrobial susceptibility testing system EUDAMED
- Model / Reference
- DL-96A EUDAMED1502040005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971025210320 EUDAMED
- Basic UDI-DI
- 697102521032010240019L EUDAMED
- Direct Marketing DI
- 06971025210320 EUDAMED
- EMDN Code
- W02030199 ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Romania 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
Fully auto microbial identification and antimicrobial susceptibility testing sy… 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 | 697102521032010240019L | 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 738d8cbf-4aeb-482f-805e-789bdbcaf833 61 fields · synced Jun 18, 2026