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MS pretreatment reagent for blood culture positive sample
EUDAMEDClass A (EU MDR)
Ref 2701200026Model MSBC-2Ref 2701200025Model MSBC-1
Identity
- Trade Name
- MS pretreatment reagent for blood culture positive sample EUDAMED
- Device Name
- MS pretreatment reagent for blood culture positive sample EUDAMED
- Model / Reference
- MSBC-2 EUDAMED2701200026 EUDAMEDMSBC-1 EUDAMED2701200025 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971025211532 EUDAMED06971025211525 EUDAMED
- Basic UDI-DI
- 69710252115321222006EY EUDAMED69710252115251116007G8 EUDAMED
- Direct Marketing DI
- 06971025211532 EUDAMED06971025211525 EUDAMED
- EMDN Code
- W010499 MICROBIOLOGY TESTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain EUDAMEDRomania EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
MS pretreatment reagent for blood culture positive sample 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 | 69710252115321222006EY | 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 524f2f44-75c9-4ed5-a18e-63d06ce5444d 61 fields · synced Jul 22, 2026
- EUDAMED b892461e-3640-44e4-bc8f-0ba7ffa5b7db 61 fields · synced May 19, 2026